HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2022-02673
- Event Type
- Death
- Date Received
- February 25, 2022
- Date of Event
- January 18, 2022
- Report Date
- October 18, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707003261
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-1266-2022
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-JUN-2021 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 10-JUN-2020, LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 17-APR-2021, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 19-APR-2021, LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 19-APR-2021, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 21-DEC-2018, LABELED FOR SINGLE USE: NO, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-JUN-2021 / SERIAL #: (B)(4), UDI #: (B)(4). DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 10-JUN-2020, LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 17-APR-2021, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 19-APR-2021, LABELED FOR SINGLE USE: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 30-APR-2022 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 19-APR-2021, LABELED FOR SINGLE USE: NO, (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650/ CATALOG #: 1650 / EXPIRATION DATE: 31-DEC-2019 / SERIAL #: (B)(4), UDI #: (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, DEVICE EVALUATED BY MANUFACTURER: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, DEVICE MFG DATE: 21-DEC-2018, LABELED FOR SINGLE USE: NO, (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: A SEGMENT OF THE DRIVELINE CABLE, ONE (1) CONTROLLER , AND TWO (2) BATTERIES WERE RETURNED FOR EVALUATION. TWO (2) BATTERIES WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR (B)(6) CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED SEGMENT OF THE DRIVELINE CABLE REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED DISCOLORATION OF THE DRIVELINE OUTER SHEATH AND DAMAGE TO THE DRIVELINE STRAIN RELIEF. THESE ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DRIVELINE OUTER SHEATH DISCOLORATION MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING DESIGN ISSUES AND/OR EXPOSURE TO UV LIGHT. A POSSIBLE ROOT CAUSE OF THE OBSERVED DRIVELINE STRAIN RELIEF DAMAGE MAY BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND/OR THE HANDLING OF THE DEVICE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THE DEVICE PASSED FUNCTIONAL TESTING. A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK ON THE CORNER OF THE CONTROLLER HOUSING. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00517125, THE ROOT CAUSE OF HAIRLINE CRACKS FOUND AT THE CORNER OF THE CONTROLLER WAS DETERMINED TO BE DUE TO ENVIRONMENTAL STRESS CRACKING FROM A COMBINATION OF CHEMICAL INCOMPATIBILITY AND MECHANICAL STRESSES. THE CHEMICAL INCOMPATIBILITY IS ATTRIBUTED TO MINERAL OIL LEACHING FROM THE CONTROLLER¿S HOUSING GASKET AND MIGRATING TO THE CONTROLLER HOUSING. THE MECHANICAL STRESSES ARE CAUSED BY THE ULTRASONIC WELDING OF INSERTS LOCATED WITHIN THE CORNERS¿ THINNER WALL. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE BATTERIES PASSED EXTERNAL VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE BATTERIES WERE UNABLE TO CHARGE OR PROVIDE POWER TO A TEST CONTROLLER. SUPPLEMENTAL TESTING REVEALED THAT ONE OF THE CELLS ON THE BATTERIES WERE UNABLE TO HOLD A CHARGE, WHICH TRIGGERED CELL-UNDER-VOLTAGE AND PACK-UNDER-VOLTAGE FLAGS, THUS RENDERING THE BATTERIES INOPERABLE. INTERNAL INSPECTION OF THE BATTERIES REVEALED A LIFTED CELL WELD ON ONE OF THE CELL PAIRS CAUSING AN INTERMITTENT CONNECTION WHICH PREVENTS THE BATTERIES FROM ADEQUATELY PROVIDING POWER TO THE CONTROLLER AND CHARGING ON A BATTERY CHARGER. ADDITIONALLY, SUPPLEMENTAL TESTING REVEALED THAT A CELL PAIR ON EACH BATTERY HAD NO VOLTAGE AND WAS UNABLE TO CHARGE, INDICATING FAULTY INTERNAL CELL PAIRS. REVIEW OF THE ALARM LOG FILE REVEALED EIGHT (8) CRITICAL BATTERY ALARMS WERE LOGGED BETWEEN 18-DEC-2021 AND 13-JAN-2022 INVOLVING (B)(6). THE DATA POINT PRIOR TO THE LAST CRITICAL BATTERY ALARM REVEALED THAT THE BATTERY WAS AT 41% RELATIVE STATE OF CHARGE (RSOC). DURING THE LAST CRITICAL BATTERY ALARM, THE BATTERY DROPPED FROM 41% RSOC TO 1% RSOC. ADDITIONALLY, SEVEN (7) CRITICAL BATTERY ALARMS WERE LOGGED BETWEEN 24-DEC-2021 AND 01-FEB-2022 INVOLVING (B)(6), AND ADDITIONAL BATTERIES DUE TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10%. REVIEW OF THE ALARM LOG FILE ALSO REVEALED TWENTY-THREE (23) POWER DISCONNECT ALARMS LOGGED BETWEEN 18-DEC-2021 AND 27-JUN-2022 INVOLVING (B)(6). DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING THAT A CELL PAIR DEPLETED BELOW A VOLTAGE THRESHOLD. LOG FILE ANALYSIS REVEALED EIGHTEEN (18) CONTROLLER POWER UP EVENTS WERE LOGGED BETWEEN 06-FEB-2022 23:22:01 AND 07-FEB-2022 11:46:16. THE DATA POINT RECORDED PRIOR TO THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 52% RSOC AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 31% RSOC. FURTHER REVIEW OF THE ALARM FILE REVEALED SIXTEEN (16) CRITICAL BATTERY ALARMS AND TWO (2) POWER DISCONNECT ALARMS INVOLVING (B)(6) WERE LOGGED BETWEEN 06-FEB-2022 19:50:43 AND 07-FEB-2022 AT 11:46:17. THE CRITICAL BATTERY ALARMS WERE DUE TO BOTH BATTERIES SUDDENLY DEPLETED COMPLETELY, RESULTING IN A LOSS OF POWER TO THE CONTROLLER. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING THAT A CELL PAIR DEPLETED BELOW A VOLTAGE THRESHOLD. ALARM LOG FILE ANALYSIS ALSO REVEALED TWO (2) LOW FLOW ALARMS WERE LOGGED ON 07-FEB-2022 AT 00:52:20 AND AT 02:17:36. IT IS LIKELY THAT THE INABILITY OF THE BATTERIES (B)(6) TO PROVIDE POWER WAS PERCEIVED AS THE REPORTED "VOLTAGE ERROR CODES CAUSING POWER CYCLING". AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LOW FLOW EVENT. BASED ON THE RISK DOC UMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. BASED ON THE AVAILABLE INFORMATI ON, A POSSIBLE ROOT CAUSE OF THE CONTROLLER LOSSES OF POWER CAN BE ATTRIBUTED TO FAULTY BATTERIES CONNECTED TO THE CONTROLLER, WHICH PREVENTED BOTH BATTERIES FROM PROVIDING POWER. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED, BUT NOT LIMITED, TO LIFTED CELL WELDS, FAULTY INTERNAL CELL PAIRS, AND TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RSOC. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS BATTERY AND "VOLTAGE ERROR CODES CAUSING POWER CYCLING" EVENT CAN BE ATTRIBUTED TO LIFTED CELL WELDS AND FAULTY INTERNAL CELL PAIRS. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED LIFTED CELL WELDS CAN BE ATTRIBUTED TO IMPROPER ASSEMBLY DURING THE MANUFACTURING PROCESS. SCAPA PR00569429 IS INVESTIGATING THIS ISSUE. (B)(6) WERE PART OF FA1257. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 10-MAR-2022 H3: YES DEV RTN TO MFR? YES H6: IMG CODE(S): G04070 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C23, C19, C07 H6: FDA CONCLUSION CODE(S): D02, D11, D12 D4: SERIAL OR LOT#: (B)(6)D9: YES, RETURN DATE: 10-MAR-2022 H3: YES DEV RTN TO MFR? YES H6: IMG CODE(S): C89532 H6: FDA METHOD CODE(S): B01, B14, B15 H6: FDA RESULTS CODE(S): C02, C020701 H6: FDA CONCLUSION CODE(S): D0301, D02 D4: SERIAL OR LOT#: (B)(6) D9: YES, RETURN DATE: 10-MAR-2022 H3: YES DEV RTN TO MFR? YES H6: FDA METHOD CODE(S): B01, B14, B15 H6: FDA RESULTS CODE(S): C02, C020701, C23 H6: FDA CONCLUSION CODE(S): D0301, D02, D11 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: IMG CODE(S): C89532 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C23 H6: FDA CONCLUSION CODE(S): D11 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND AN UPDATE TO INVESTIGATION SUMMARY. H6 EVALUATION RESULT CODE C020701 AND EVALUATION CONCLUSION CODE D02 FOR (B)(6) AND (B)(6) WERE REMOVED FROM THE EVENT. REVISED PRODUCT EVENT SUMMARY: A SEGMENT OF THE DRIVELINE CABLE ASSOCIATED WITH (B)(6), ONE (1) CONTROLLER ((B)(6)), AND TWO (2) BATTERIES ((B)(6)) WERE RETURNED FOR EVALUATION. TWO (2) BATTERIES ((B)(6)) WERE NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION FOR (B)(6) CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE RETURNED DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED SEGMENT OF THE DRIVELINE CABLE REVEALED THAT THE DEVICE PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED DISCOLORATION OF THE DRIVELINE OUTER SHEATH AND DAMAGE TO THE DRIVELINE STRAIN RELIEF. THESE ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DRIVELINE OUTER SHEATH DISCOLORATION MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING DESIGN ISSUES AND/OR EXPOSURE TO UV LIGHT. A POSSIBLE ROOT CAUSE OF THE OBSERVED DRIVELINE STRAIN RELIEF DAMAGE MAY BE ATTRIBUTED, BUT NOT LIMITED, TO WEAR AND/OR THE HANDLING OF THE DEVICE. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THE DEVICE PASSED FUNCTIONAL TESTING. A VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED A HAIRLINE CRACK ON THE CORNER OF THE CONTROLLER HOUSING. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THIS IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00517125, THE ROOT CAUSE OF HAIRLINE CRACKS FOUND AT THE CORNER OF THE CONTROLLER WAS DETERMINED TO BE DUE TO ENVIRONMENTAL STRESS CRACKING FROM A COMBINATION OF CHEMICAL INCOMPATIBILITY AND MECHANICAL STRESSES. THE CHEMICAL INCOMPATIBILITY IS ATTRIBUTED TO MINERAL OIL LEACHING FROM THE CONTROLLER¿S HOUSING GASKET AND MIGRATING TO THE CONTROLLER HOUSING. THE MECHANICAL STRESSES ARE CAUSED BY THE ULTRASONIC WELDING OF INSERTS LOCATED WITHIN THE CORNERS¿ THINNER WALL. FAILURE ANALYSIS OF (B)(6) AND (B)(6)REVEALED THAT THE BATTERIES PASSED EXTERNAL VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE BATTERIES WERE UNABLE TO CHARGE OR PROVIDE POWER TO A TEST CONTROLLER. SUPPLEMENTAL TESTING REVEALED THAT ONE OF THE CELLS ON THE BATTERIES WERE UNABLE TO HOLD A CHARGE, WHICH TRIGGERED CELL-UNDER-VOLTAGE AND PACK-UNDER-VOLTAGE FLAGS, THUS RENDERING THE BATTERIES INOPERABLE. INTERNAL INSPECTION OF THE BATTERIES REVEALED A LIFTED CELL WELD ON ONE OF THE CELL PAIRS CAUSING AN INTERMITTENT CONNECTION WHICH PREVENTS THE BATTERIES FROM ADEQUATELY PROVIDING POWER TO THE CONTROLLER AND CHARGING ON A BATTERY CHARGER. ADDITIONALLY, SUPPLEMENTAL TESTING REVEALED THAT A CELL PAIR ON EACH BATTERY HAD NO VOLTAGE AND WAS UNABLE TO CHARGE, THIS OBSERVATION IS RELATED TO THE OBSERVED LIFTED CELL WELD. REVIEW OF THE ALARM LOG FILE REVEALED EIGHT (8) CRITICAL BATTERY ALARMS WERE LOGGED BETWEEN 18/DEC/2021 AND 13/JAN/2022 INVOLVING (B)(6). THE DATA POINT PRIOR TO THE LAST CRITICAL BATTERY ALARM REVEALED THAT THE BATTERY WAS AT 41% RELATIVE STATE OF CHARGE (RSOC). DURING THE LAST CRITICAL BATTERY ALARM, THE BATTERY DROPPED FROM 41% RSOC TO 1% RSOC. ADDITIONALLY, SEVEN (7) CRITICAL BATTERY ALARMS WERE LOGGED BETWEEN 24/DEC/2021 AND 01/FEB/2022 INVOLVING (B)(6), AND ADDITIONAL BATTERIES DUE TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10%. REVIEW OF THE ALARM LOG FILE ALSO REVEALED TWENTY-THREE (23) POWER DISCONNECT ALARMS LOGGED BETWEEN 18/DEC/2021 AND 27/JUN/2022 INVOLVING (B)(6). DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING THAT A CELL PAIR DEPLETED BELOW A VOLTAGE THRESHOLD. LOG FILE ANALYSIS REVEALED EIGHTEEN (18) CONTROLLER POWER UP EVENTS WERE LOGGED BETWEEN (B)(6) 2022 23:22:01 AND (B)(6) 2022 11:46:16. THE DATA POINT RECORDED PRIOR TO THE LOSSES OF POWER REVEALED THAT (B)(6) WAS CONNECTED TO POWER PORT ONE (1) WITH 52% RSOC AND (B)(6) WAS CONNECTED TO POWER PORT TWO (2) WITH 31% RSOC. FURTHER REVIEW OF THE ALARM FILE REVEALED SIXTEEN (16) CRITICAL BATTERY ALARMS AND TWO (2) POWER DISCONNECT ALARMS INVOLVING (B)(6) WERE LOGGED BETWEEN (B)(6) 2022 19:50:43 AND (B)(6) 2022 AT 11:46:17. THE CRITICAL BATTERY ALARMS WERE DUE TO BOTH BATTERIES SUDDENLY DEPLETED COMPLETELY, RESULTING IN A LOSS OF POWER TO THE CONTROLLER. DURING THE POWER DISCONNECT ALARMS, A SAFETY ALERT WORD (SAW) VALUE WAS RECORDED INDICATING THAT A CELL PAIR DEPLETED BELOW A VOLTAGE THRESHOLD. ALARM LOG FILE ANALYSIS ALSO REVEALED TWO (2) LOW FLOW ALARMS WERE LOGGED ON (B)(6) 2022 AT 00:52:20 AND AT 02:17:36. IT IS LIKELY THAT THE INABILITY OF THE BATTERIES (B)(6) TO PROVIDE POWER WAS PERCEIVED AS THE REPORTED "VOLTAGE ERROR CODES CAUSING POWER CYCLING". AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. BASED ON THE AVAILABLE INFORMATION, THE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE REPORTED LOW FLOW EVENT. BASED ON THE RISK DOC UMENTATION, POSSIBLE CAUSES OF THE REPORTED LOW FLOW EVENT MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO THROMBUS AT THE INFLOW CANNULA/OUTFLOW GRAFT, CONSTRICTION AT THE OUTFLOW GRAFT, AND/OR POOR VAD FILLING. BASED ON THE AVAILABLE INFORMATI ON, A POSSIBLE ROOT CAUSE OF THE CONTROLLER LOSSES OF POWER CAN BE ATTRIBUTED TO FAULTY BATTERIES CONNECTED TO THE CONTROLLER, WHICH PREVENTED BOTH BATTERIES FROM PROVIDING POWER. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. BASED ON THE AVAILABLE INFORMATION, A POSSIBLE ROOT CAUSE OF THE REPORTED CRITICAL BATTERY ALARMS CAN BE ATTRIBUTED, BUT NOT LIMITED, TO LIFTED CELL WELDS AND TO THE PATIENT ALLOWING THE BATTERIES TO DEPLETE BELOW 10% RSOC. THE MOST LIKELY ROOT CAUSE OF THE REPORTED POWER DISCONNECT ALARMS BATTERY AND "VOLTAGE ERROR CODES CAUSING POWER CYCLING" EVENT CAN BE ATTRIBUTED TO LIFTED CELL WELDS. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED LIFTED CELL WELDS CAN BE ATTRIBUTED TO IMPROPER ASSEMBLY DURING THE MANUFACTURING PROCESS. CAPA PR00569429 IS INVESTIGATING THIS ISSUE. (B)(6) ARE IN SCOPE OF FA1257 WHICH WAS INITIATED FOR BATTERIES WITH A WELDING DEFECT IN A SPOT WELD OF THE NICKEL STRIP THAT CONNECTS THE 5X AND 3X CELL PACK. ADDITIONAL PRODUCTS D4:SERIAL #: (B)(6), H6: IMG CODE(S): G04139 D4:SERIAL#: (B)(6), H6: IMG CODE(S): G04139 INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. A VOLUNTARY MEDWATCH FORM 3500 WAS RECEIVED (REPORT #MW5108023); SINCE F10 IS NOT CONTAINED ON THAT FORM, SELECT FIELDS IN SECTION F HAVE BEEN POPULATED BY THE MANUFACTURER. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 10-MAR-2022, H3: DEV RTN TO MFR? YES H6: PATIENT IME CODE(S): E0602, D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 10-MAR-2022, H3: DEV RTN TO MFR? YES, H6: PATIENT IME CODE(S): E0602, D4: SERIAL OR LOT#: (B)(6), D9: YES, RETURN DATE: 10-MAR-2022, H3: DEV RTN TO MFR? YES, H6: PATIENT IME CODE(S): E0602, D4: SERIAL OR LOT#: (B)(6), H6: PATIENT IME CODE(S): E0602, D4: SERIAL OR LOT#:(B)(6), H6: PATIENT IME CODE(S): E0602. INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
A SUPPLEMENTAL CORRECTION IS BEING SUBMITTED FOR: INCLUSION OF DATA IN: H7: FROM BLANK TO CHECK RECALL H9: FROM BLANK TO: 3007042319-05-16-22-002-R. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD ON COLLEGE CAMPUS AND THE CAUSE OF DEATH WAS UNKNOWN. REVIEW OF LOGFILES SHOWED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOW ALARMS ON THE SAME DAY. THERE WERE TWO BATTERIES THAT EXHIBITED POWER DISCONNECT AND CRITICAL BATTERY ALARMS ASSOCIATED WITH MULTIPLE LOSSES OF POWER TO THE CONTROLLER SINCE THE DAY BEFORE. OF NOTE, EIGHT DAYS PRIOR, TWO MORE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS INCLUDING THE PREVIOUS BATTERIES. IN ADDITION, ELEVEN DAYS EARLIER THE SAME TWO INITIAL BATTERIES DISPLAYED MULTIPLE POWER DISCONNECT ALARMS.
IT WAS REPORTED THAT THE PATIENT WAS FOUND DEAD ON COLLEGE CAMPUS AND THE CAUSE OF DEATH WAS UNKNOWN. REVIEW OF LOGFILES SHOWED THAT THE VENTRICULAR ASSIST DEVICE (VAD) EXHIBITED LOW FLOW ALARMS ON THE SAME DAY. THERE WERE TWO BATTERIES THAT EXHIBITED POWER DISCONNECT AND CRITICAL BATTERY ALARMS ASSOCIATED WITH MULTIPLE LOSSES OF POWER TO THE CONTROLLER SINCE THE DAY BEFORE. OF NOTE, EIGHT DAYS PRIOR, TWO MORE BATTERIES EXHIBITED CRITICAL BATTERY ALARMS INCLUDING THE PREVIOUS BATTERIES. IN ADDITION, ELEVEN DAYS EARLIER THE SAME TWO INITIAL BATTERIES DISPLAYED MULTIPLE POWER DISCONNECT ALARMS.
IT WAS FURTHER REPORTED THAT THE PATIENT SUFFERED CARDIAC ARREST WHICH WAS SECONDARY TO PRESUMED VAD FAILURE. IT WAS STATED THAT LOG FILES REVEALED THE CONTROLLER WAS ¿CONNECTED TO TWO BATTERIES WITH VOLTAGE ERROR CODES CAUSING POWER CYCLING AND ULTIMATELY LEADING TO PUMP STOPPAGE¿.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1680397 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707003261 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 21 YR | Male | Death |