HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0
Report
- Report Number
- 3007042319-2021-06307
- Event Type
- Malfunction
- Date Received
- September 15, 2021
- Date of Event
- August 30, 2021
- Report Date
- January 5, 2022
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- UDI-DI
- 00888707000475
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) , H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) , H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) , H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) , H3: YES H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #: (B)(6) H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D01 D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: SERIAL #:(B)(6) , H6: IMG CODE(S): G0403401 H6: FDA METHOD CODE(S): B01, B15 H6: FDA RESULTS CODE(S): C04 H6: FDA CONCLUSION CODE(S): D02 PRODUCT EVENT SUMMARY: THE CONTROLLER AND SIX BATTERIES 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 THE RETURNED BATTERIES REVEALED THAT THE UNITS PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. FAILURE ANALYSIS OF THE RETURNED CONTROLLER REVEALED THAT THE UNIT PASSED FUNCTIONAL TESTING. VISUAL INSPECTION REVEALED CONTAMINATION WITHIN BOTH POWER PORTS, THE SERIAL PORT, AND PUMP CONNECTOR. THE OBSERVED SERIAL PORT AND PUMP CONNECTOR CONTAMINATION ARE ADDITIONAL FINDINGS NOT RELATED TO THE REPORTED EVENT. 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 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 MOMENTARY DISCONNECTIONS INVOLVING (B)(6) , (B)(6) , (B)(6) , (B)(6) ,(B)(6) , AND (B)(6) . LOG FILE ANALYSIS REVEALED TEN (10) CONTROLLER POWER UP EVENTS WITH ASSOCIATED MOTOR START EVENTS LOGGED ON (B)(6) 2021 AT 12:59:53, ON (B)(6) 2021 AT 04:28:08, ON (B)(6) 2021 AT 02:33:27, ON (B)(6) 2021 AT 00:17:00 AND 05:46:20, ON (B)(6) 2021 AT 21:01:09, ON (B)(6) 2021 AT 22:13:31, ON (B)(6) 2021 AT 16:44:52, ON (B)(6) 2021 AT 21:23:34, AND ON (B)(6) 2021 AT 05:56:00. SEVERAL MOMENTARY DISCONNECTIONS WERE OBSERVED LEADING UP TO THE LOSS OF POWER ON (B)(6) 2021. THE CONTROLLER WAS WITHOUT POWER FOR AN AVERAGE OF NINE (9) SECONDS PER LOSS OF POWER. LOSS OF POWER WILL RESULT IN A CONTINUOUS AUDIBLE ALARM. MOMENTARY DISCONNECTIONS WILL RESULT IN AN AUDIBLE TONE. IT IS LIKELY THE OBSERVED MOMENTARY DISCONNECTIONS WERE RELATED TO THE REPORTED "BRIEF ALARM". AS A RESULT, THE REPORTED LOSS OF POWER AND "BRIEF ALARM" EVENTS WERE CONFIRMED. ADDITIONALLY, REVIEW OF DATA LOG FILE REVEALED AN INSTANCE INVOLVING (B)(6) WHERE THE BATTERY'S RELATIVE STATE OF CHARGE (RSOC) VALUE WAS LOGGED BETWEEN 101-201, WHICH IS INDICATIVE OF A COMMUNICATION ERROR. THE OBSERVED COMMUNICATION ERROR IS AN ADDITIONAL FINDING NOT RELATED TO THE REPORTED EVENT. A POWER SOURCE LUBRICATION PROCEDURE HAD BEEN PERFORMED ON (B)(6) AND (B)(6) IN ACCORDANCE WITH THE REQUIREMENTS UNDER FSCA CVG-18-Q4-19 ON (B)(6) 2019. THERE WAS NO EVIDENCE OF LUBRICATION SERVICING ON THE REMAINING ASSOCIATED BATTERIES. POSSIBLE ROOT CAUSES OF THE OBSERVED COMMUNICATION ERROR CAN BE ATTRIBUTED TO A MOMENTARY DISCONNECTION ON THE COMMUNICATION PIN OF THE CONTROLLER, THE CONTROLLER NOT RECEIVING RESPONSES FROM THE BATTERIES, AND/OR DUE TO THE PACKET ERROR CHECKING METHOD DETECTING BIT ERRORS. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED CONTAMINATION EVENT CAN BE ATTRIBUTED TO HANDLING OF THE DEVICE. A POSSIBLE ROOT CAUSE OF THE LOSSES OF POWER CAN BE ATTRIBUTED TO A DISCONNECTION OF BOTH POWER SOURCES AND/OR TO AN INTERMITTENT DISCONNECTION ON ONE OR BOTH POWER SOURCES. CAPA PR00551638 IS INVESTIGATING CONTROLLER LOSSES OF POWER. THE MOST LIKELY ROOT CAUSE OF THE REPORTED "BRIEF ALARM" 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 PINS. CAPA PR00389403 INVESTIGATED MOMENTARY DISCONNECTIONS PRIOR TO LUBRICATION SERVICING. EVEN THOUGH THIS CAPA IS CLOSED, (B)(6) , (B)(6) , (B)(6) , (B)(6) , AND (B)(6) FALLS WITHIN THE BOUNDS OF THIS CAPA. 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 AND CORRECTIONS. NEWLY RECEIVED INFORMATION INDICATES THAT BATTERIES WERE ALSO INVOLVED WITH THIS EVENT. SECTION D4 UDI NUMBER WAS CORRECTED FROM (B)(4) TO (B)(4). SECTION H4 DEVICE MFG DATE WAS CORRECTED FROM 30-SEP-2018 TO 19-SEP-2018. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ BATTERY D4: MODEL #: 1650 / CATALOG #: 1650 / EXPIRATION DATE: 31-OCT-2019 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 02-OCT-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-OCT-2019 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 16-OCT-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-JUL-2020 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 20-JUL-2019 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-2020 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 21-JUL-2019 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-2020 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 20-JUL-2019 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-OCT-2019 / SERIAL #: (B)(6) UDI #: (B)(4) D9: YES, RETURN DATE: 20-SEP-2021 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN DEV RTN TO MFR? YES H4: MFG DATE: 16-OCT-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.
IT WAS FURTHER REPORTED THAT SIX BATTERIES WERE SUSPECTED TO HAVE CONTRIBUTED TO THE CONTROLLER POWER LOSSES DUE TO CONNECTION ERRORS. THE BATTERIES WERE REPLACED.
CONCOMITANT MEDICAL PRODUCTS: DTMA1Q1 ICD, 429888 LEAD, AND 407652 LEAD, IMPLANTED: (B)(6) 2018; 694765 LEAD, IMPLANTED: (B)(6) 2008 .INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THE CONTROLLER EXHIBITED FIVE CONTROLLER POWER UP ALARMS DUE TO UNEXPECTED POWER LOSS. THE PATIENT STATED THAT OCCASIONALLY WOULD HEAR A VERY BRIEF ALARM THAT WOULD SELF-RESOLVE, YET NOTHING APPEARED ON THE CONTROLLER. THE CONTROLLER WAS EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1372104 | HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420 | 00888707000475 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Male | 1103 VAD| 1103 VAD |