HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP
Report
- Report Number
- 3007042319-2021-05628
- Event Type
- Malfunction
- Date Received
- August 11, 2021
- Date of Event
- August 5, 2021
- Report Date
- March 29, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707002639
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. PRODUCT EVENT SUMMARY: THE PUMP (HW31626) AND THREE (3) BATTERIES (BAT902628, BAT757635, BAT757638) WERE NOT RETURNED FOR EVALUATION. ONE CONTROLLER (CON414699) AND SEVEN BATTERIES (BAT902626, BAT902629, BAT902625, BAT757641, BAT757640, BAT757639, BAT757636) WERE RETURNED FOR EVALUATION. 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 BAT902626, BAT757641, AND BAT757640 REVEALED THAT THE BATTERIES PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF BAT757639 AND BAT757636 REVEALED THAT THE BATTERIES PASSED FUNCTIONAL TESTING. VISUAL INSPECTION OF BAT757639 REVEALED A TEAR IN THE OUTER SHEATH OF THE CABLE ASSEMBLY. VISUAL INSPECTION OF BAT757636 REVEALED A TEAR IN THE OUTER SHEATH NEAR THE STRAIN RELIEF OF THE CABLE ASSEMBLY. THESE OBSERVATIONS DID NOT AFFECT THE FUNCTIONALITY OF THE DEVICE. FAILURE ANALYSIS OF BAT902629 AND BAT902625 REVEALED THAT THE BATTERIES PASSED VISUAL INSPECTION. FUNCTIONAL TESTING OF BAT902629 REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE OR PROVIDE POWER. DURING FUNCTIONAL TESTING, TEST EQUIPMENT WAS UNABLE TO PROPERLY READ THE BATTERY STATUS DUE TO A COMMUNICATION PROBLEM WITH THE MAIN INTEGRATED CIRCUIT (IC). INTERNAL INSPECTION OF THE BATTERY DID NOT REVEAL ANY ABNORMALITIES THAT MAY HAVE CONTRIBUTED TO THE INABILITY TO COMMUNICATE TO THE MAIN IC. AN ATTEMPT TO RESET THE MAIN IC WAS ABLE TO REESTABLISH THE BATTERY FUNCTIONALITY. FUNCTIONAL TESTING OF BAT902625 REVEALED THAT THE BATTERY WAS UNABLE TO CHARGE OR PROVIDE POWER. FURTHER TESTING REVEALED THAT THE DISCHARGE FIELD-EFFECTIVE TRANSISTOR (FET) WAS DISABLED AND THE PACK UNDER VOLTAGE (PUV) FLAG ENABLED. A PACK-UNDER-VOLTAGE FLAG IS TRIGGERED WHEN THE BATTERY PACK FALLS BELOW A VOLTAGE THRESHOLD. INTERNAL INSPECTION DID NOT REVEAL ANY ANOMALIES. DURING SUPPLEMENTAL TESTING, IT WAS DETERMINED THAT TEST EQUIPMENT HAD REGISTERED CELL PAIR VOLTAGE VALUES WHICH DIFFERED FROM THOSE MEASURED WHEN THE BATTERY WAS OPENED. THESE OBSERVATIONS ARE INDICATIVE OF A FAULT OF THE INTEGRATED CIRCUIT (IC) THAT CONTROLS THE BATTERY. ADDITIONALLY, THE BATTERY WAS UNABLE TO BE FULLY RESET, INDICATING A FAULT WITH THE MAIN IC. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE CONTROLLER PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. SUPPLEMENTAL TESTING WAS PERFORMED, AND THE TEST RESULTS REVEALED THAT THE GOLD-PLATING OF THE PINS WERE WORN, EXPOSING THE BASE METAL. THE EXPOSURE OF THE BASE METAL IS SUSCEPTIBLE TO THE EFFECTS OF CORROSION. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER IN USE DURING THE REPORTED EVENT, CON414699, CONTAINED A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF THE DATA LOG FILE REVEALED SEVERAL PREMATURE POWER SWITCHING EVENTS THAT WERE DUE TO MOMENTARY DISCONNECTIONS INVOLVING BAT902626, BAT902628, BAT902629, BAT902625, BAT757640, BAT757639, AND BAT757635. ADDITIONALLY, A PREMATURE POWER SWITCHING EVENT THAT WAS DUE TO A COMMUNICATION ERROR WAS LOGGED ON 05-AUG-2021 AT 21:38:04 INVOLVING BAT902626. LOG FILE ANALYSIS REVEALED TEN (10) CONTROLLER POWER UP EVENTS WITH SUCCESSFUL ASSOCIATED MOTOR START EVENTS LOGGED ON 25-JUL-2021 AT 13:53:29, ON 27-JUL-2021 AT 01:57:14, 01:57:36, 01:58:37, 01:59:39, 14:28:17, 14:28:38, ON 30-JUL-2021 AT 03:52:32, ON 31-JUL-2021 AT 01:35:12, AND ON 05-AUG-2021 AT 21:40:41. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF 13 SECONDS PER LOSS OF POWER. A CONTROLLER LOSS OF POWER EVENT WILL RESULT IN THE PUMP STOPPING. WHEN THE CONTROLLER STARTS UP, THE LED INDICATOR FOR BOTH POWER SOURCES AND THE ALARM INDICATOR ON THE CONTROLLER'S FRONT PANEL WILL FLASH RED FOR A BRIEF MOMENT. ANALYSIS OF THE ALARM LOG FILE REVEALED ONE (1) CRITICAL BATTERY ALARM LOGGED ON 04-AUG-2021 AT 19:25:15 DUE TO A COMMUNICATION ERROR INVOLVING BAT90 2626. ANALYSIS OF THE DATA LOG FILE ALSO REVEALED INSTANCES INVOLVING BAT902625 AND BAT902626 WHERE THE BATTERIES' RELATIVE STATE OF CHARGE (RSOC) WAS BETWEEN 101-201, WHICH IS INDICATIVE OF COMMUNICATION ERRORS. A COMMUNICATION ERROR WILL TRIGGER A POWER DISCONNECT ALARM IF THE OTHER POWER SOURCE HAS AN RSOC GREATER THAN 25%. ADDITIONAL PRODUCTS: D4: CON414699 H6: IMG CODE(S): G04035, G0403401 H6: FDA DEVICE CODE(S): A0708, A141204 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04, C06 H6: FDA CONCLUSION CODE(S): DXX D4: BAT902626 H6: IMG CODE(S): G02002, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): DXX D4: BAT902628 H6: IMG CODE(S):G02002, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): DXX D4: BAT902629 H6: IMG CODE(S): G02002, G02013, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04, C21 H6: FDA CONCLUSION CODE(S): DXX D4: BAT902625 H6: IMG CODE(S): G02002, G02013, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT757641 H6: IMG CODE(S): G02002 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT757640 H6: IMG CODE(S): G02002, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT757639 H6: IMG CODE(S): G02002, G02004, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT757636 H6: IMG CODE(S): G02002, G02004 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT7576365 H6: IMG CODE(S): G02002, G0403401 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX D4: BAT757638 H6: IMG CODE(S): G02002, G04105 H6: FDA DEVICE CODE(S): A0705 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): CXX H6: FDA CONCLUSION CODE(S): DXX 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. ADDITIONAL PRODUCTS: D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-JUL-2021, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); H4: MFG DATE: 25-JUL-2020; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-JUL-2021, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); H4: MFG DATE: 25-JUL-2020; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-JUL-2021, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: YES. RETURN DATE: 18-AUG-2021; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN ADVERTENT TO MFR? YES.; H4: MFG DATE: 25-JUL-2020; H5: NO; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-JUL-2021, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 25-JUL-2020; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO.; DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16; D1: HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY; D4: MODEL #: 1650, CATALOG #: 1650, EXPIRATION DATE: 31-AUG-2019, SERIAL OR LOT#: (B)(6), UDI #: (B)(4); D9: NO.; H3: NO. DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN; H4: MFG DATE: 22-AUG-2018; H5: NO.; H6: PATIENT IME CODE(S): E2403; H6: IMF CODE(S): F26; H6: IMG CODE(S): G02002; H6: FDA DEVICE CODE(S): A0705; H6: FDA RESULTS CODE(S): C21; H6: FDA CONCLUSION CODE(S): D16. 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 AN UPDATE TO THE PRODUCT EVENT SUMMARY AND ANNEX C AND D CODES. PRODUCT EVENT SUMMARY: BASED ON AN INVESTIGATION CONDUCTED UNDER CAPA PR00519785, THE MOST LIKELY ROOT CAUSE OF THE INABILITY OF (B)(6) AND (B)(6) TO CHARGE AND PROVIDE POWER EVENTS HAS BEEN ATTRIBUTED TO THE BATTERY CONNECTOR INTERFACE DESIGN WHICH DOES NOT GUARANTEE THE DESIRED CONNECTION ANGLE IN SOME USE CONDITIONS ADDITIONAL PRODUCTS: D4: SERIAL #: (B)(6); H6: FDA RESULTS CODE(S): C02 H6: FDA CONCLUSION CODE(S): D01 D4: SERIAL #: (B)(6) H6: FDA RESULTS CODE(S): C02 H6: FDA CONCLUSION CODE(S): D01 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 A CORRECTION TO H10 ADDITIONAL PRODUCTS FDA CODES. ADDITIONAL PRODUCTS: D4: CON414699 H6: FDA CONCLUSION CODE(S): D01, D02, D15 D4: BAT902626 H6: FDA CONCLUSION CODE(S): D02 D4: BAT902628 H6: FDA CONCLUSION CODE(S): D02 D4: BAT902629 H6: FDA CONCLUSION CODE(S): D02, D16 D4: BAT902625 H6: FDA RESULTS CODE(S): C04, C21 H6: FDA CONCLUSION CODE(S): D02, D16 D4: BAT757641 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 D4: BAT757640 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D4: BAT757639 H6: FDA RESULTS CODE(S): C04, C07 H6: FDA CONCLUSION CODE(S): D01, D11 D4: BAT757636 H6: FDA RESULTS CODE(S): C07 H6: FDA CONCLUSION CODE(S): D11 D4: BAT7576365 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D4: BAT757638 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 BATTERY LIGHTS ¿WENT RED¿. FIRST ON ONE SIDE AND THEN THE OTHER, AND THE MESSAGE ON THE CONTROLLER SCREEN SAID ¿CONNECT A POWER SOURCE¿. AT THAT POINT, THE CONTROLLER WAS EXCHANGED. IT WAS NOTED, THAT THIS BATTERY BEHAVIOR DID OCCUR ON ONE SIDE, PRIOR TO THE INCIDENT. AND IT WAS SUSPECTED THAT THE BATTERY WAS FAULTY. THE PATIENT DISCONNECTED THE BATTERY, DID SOMETHING TO CLEAN IT, AND THEN RECONNECTED THE BATTERY. THE PATIENT DESCRIBED POWER SWITCHING AND CRITICAL BATTERY ALARMS. WHICH WERE CONFIRMED, AS WHAT PROMPTED THE PATIENT TO EXCHANGE THE CONTROLLER. IT WAS ALSO STATED, THAT ONE OF THE BATTERIES WASN¿T REGISTERING ON THE CONTROLLER. REVIEW OF LOG FILES REVEALED, ONE OF THE BATTERIES EXHIBITED A COMMUNICATION ERROR AS WELL. THE BATTERIES WILL BE REPLACED.
ADDITIONAL INFORMATION HAS BEEN REQUESTED REGARDING THE BATTERY SERIAL NUMBERS AND OTHER DETAILS OF THE EVENT, BUT IT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. IF ADDITIONAL INFORMATION IS RECEIVED, THE EVENT WILL BE UPDATED AND A SUPPLEMENTAL REPORT WILL BE SENT. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ CONTROLLER 2.0 , MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 31-DEC-2021 / SERIAL #: (B)(4) / UDI #: (B)(4). DEVICE AVAILABLE FORE EVALUATION?: NO. MFG DATE: 02-DEC-2020. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNKNOWN / CATALOG #: UNKNOWN / EXPIRATION DATE: UNKNOWN / SERIAL #: UNKNOWN / UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION?: NO. MFG DATE: UNKNOWN. LABELED FOR SINGLE USE?: NO. (B)(4). BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY, MODEL #: UNKNOWN / CATALOG #: UNKNOWN / EXPIRATION DATE: UNKNOWN / SERIAL #: UNKNOWN UDI #: ASKU. DEVICE AVAILABLE FOR EVALUATION: NO. MFG DATE: UNKNOWN. 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 CONTROLLER LOST POWER AND THE VENTRICULAR ASSIST DEVICE (VAD) STOPPED. POWER SOURCES WERE CHANGED, BUT THE VAD WOULD NOT RESTART. THE CONTROLLER WAS EXCHANGED AND THE VAD SUCCESSFULLY RESTARTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207632 | HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1103 | 00888707002639 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 51 YR | Unknown |