HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2020-07863
- Event Type
- Malfunction
- Date Received
- December 15, 2020
- Date of Event
- December 8, 2020
- Report Date
- February 23, 2021
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000420
- PMA / PMN Number
- P100047
- Removal / Correction Number
- Z-0067-2019
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- NURSE
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR AN UPDATE TO B5 AND PRODUCT RETURN. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4:SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER D4: SERIAL#: (B)(6) D9: YES, RETURN DATE: 12-JAN-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN 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 REPORT IS BEING SUBMITTED FOR DEVICE INVESTIGATION. PRODUCT EVENT SUMMARY: THE CONTROLLER, BATTERIES, CONTROLLER AC ADAPTER, AND CONTROLLER DC ADAPTER WERE RETURNED FOR EVALUATION. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE DEVICES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF (B)(6) REVEALED THAT THE BATTERY PASSED VISUAL INSPECTION. FUNCTIONAL TESTING REVEALED THAT THE VOLTAGE OF ONE THE CELL PAIRS WAS BELOW THE VOLTAGE THRESHOLD. IT WAS NOTED THAT THERE WAS A TIME DIFFERENCE OF 1421 DAYS BETWEEN THE MANUFACTURING DATE AND THE REPORTED EVENT DATE. THIS INDICATES THAT THE BATTERY WAS MOST LIKELY NOT IN USE FOR AN EXTENDED PERIOD OF TIME. HENCE, THE BATTERY WAS SUSCEPTIBLE TO AN EXPECTED DEGRADATION OF CAPACITY AS A RESULT OF NON-USAGE. OF NOTE, IT WAS OBSERVED THAT THE BATTERIES HAD EXCEEDED THE USEFUL OPERATING LIFE OF 500 CHARGE AND DISCHARGE CYCLES. THESE OBSERVATIONS ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED 500 CHARGE AND DISCHARGE CYCLES CAN BE ATTRIBUTED TO THE BATTERIES REACHING THE END OF THEIR USEFUL LIFE. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DEGRADED CELL PAIR CAN BE ATTRIBUTED TO AN EXPECTED DEGRADATION AS A RESULT OF NON-USAGE OVER TIME. THE REPORTED EVENTS COULD NOT BE DUPLICATED DURING BENCH TESTING; THE BATTERIES AND ADAPTERS DID NOT EXPERIENCE A POWER SWITCHING EVENT AND WERE ABLE TO ADEQUATELY PROVIDE POWER TO A TEST CONTROLLER. FAILURE ANALYSIS OF THE RETURNED CONTROLLERS REVEALED THAT THE DEVICES PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF (B)(6) REVEALED CONTAMINATION WITHIN BOTH POWER PORTS. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. ADDITIONALLY, VISUAL INSPECTION UNDER 10X MAGNIFICATION REVEALED HAIRLINE CRACKS AROUND BOTH POWER PORTS OF (B)(6) AND A HAIRLINE CRACK AROUND POWER PORT TWO OF (B)(6). AN INTERNAL INSPECTION OF EACH CONTROLLER DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACKS ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00381374, THE ROOT CAUSE OF THE HAIRLINE CRACKS WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) FALL WITHIN THE BOUNDS OF THIS CAPA. REVIEW OF THE CONTROLLER LOG FILES PERTAINING TO (B)(6) REVEALED THAT THE DEVICE WAS NOT IN USE DURING THE REPORTED EVENT DATE AND WAS LIKELY THE BACKUP CONTROLLER. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, (B)(6), CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. REVIEW OF THE AVAILABLE DATA LOG FILES DID NOT REVEAL ANY PREMATURE POWER SWITCHING EVENTS OR MOMENTARY DISCONNECTIONS THAT DID NOT LEAD TO PREMATURE POWER SWITCHING EVENTS WITHIN THE ANALYZED PERIOD. THE CONTROLLER CAN ONLY STORE A MAXIMUM OF 30 DAYS OF DATA. AFTER REACHING THE LIMIT, THE CONTROLLER INITIATES A FIRST-IN FIRST-OUT METHOD WHEREBY THE OLDEST DATA POINT IS DELETED TO ALLOW THE NEWEST DATA POINT TO BE RECORDED. THUS, DATA LOGS PRIOR TO 07-DEC-2020 WAS NOT AVAILABLE FOR ANALYSIS. AS A RESULT, THE REPORTED EVENTS COULD NOT BE CONFIRMED. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON THE BATTERIES IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON 27-JUL-2018. THERE IS NO EVIDENCE THAT THE LUBRICATION SERVICING WAS PERFORMED ON THE ADAPTERS. APPLICABLE RISK DOCUMENTATION, EXPERIENCE WITH EVENTS OF SIMILAR CIRCUMSTANCES, AND THE AVAILABLE INFORMATION WERE CONSIDERED; A POSSIBLE ROOT CAUSE OF THE REPORTED PREMATURE POWER SWITCHING EVENT CAN BE ATTRIBUTED, BUT NOT LIMITED TO COMMUNICATION ERRORS, MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS, AND/OR MOMENTARY DISCONNECTIONS DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE PINS. THE MOST LIKELY ROOT CAUSE OF THE REPORTED "INTERMITTENT BEEPS" EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS DUE TO CONTAMINATION WITHIN THE POWER PORTS AND/OR DUE TO TEMPORARY CORROSION OF THE CONTROLLER-PORT/POWER-SOURCE P INS. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: (B)(6) H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19, C020701 H6: FDA CONCLUSION CODE(S): D02, D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D1105 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C07 H6: FDA CONCLUSION CODE(S): D01 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: SERIAL OR LOT#: (B)(6), H3: YES H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 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.
IT WAS FURTHER REPORTED THAT THE BATTERIES, CONTROLLERS, CONTROLLER AC ADAPTER AND CONTROLLER DC ADAPTER WERE EXCHANGED.
INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-APR-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-APR-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-JAN-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-JAN-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-MAY-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-MAY-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-MAY-2018 / SERIAL OR LOT#: (B)(4) , UDI #: (B)(4). MFG DATE: 31-MAY-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-JAN-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-JAN-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-MAY-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-MAY-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0, MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-AUG-2018 / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: 31-AUG-2017. LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER AC ADAPTER, MODEL #: 1430 / CATALOG #: 1430 / EXPIRATION DATE: (B)(4) / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: (B)(4). LABELED FOR SINGLE USE: NO. (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER DC ADAPTER, MODEL #: 1440 / CATALOG #: 1440 / EXPIRATION DATE: (B)(4) / SERIAL OR LOT#: (B)(4), UDI #: (B)(4). MFG DATE: (B)(4). LABELED FOR SINGLE USE: NO. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE BATTERIES, CONTROLLERS, CONTROLLER AC ADAPTER AND CONTROLLER DC ADAPTER EXHIBITED POWER SWITCHING. THE CONTROLLERS ALSO EXHIBITED INTERMITTENT BEEPS. THE DEVICES HAD BEEN PREVIOUSLY LUBRICATED. THE BATTERIES, CONTROLLERS, CONTROLLER AC ADAPTER AND CONTROLLER DC ADAPTER REMAIN IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1478600 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSIST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000420 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 28 YR | 1103 VAD. |