HEARTMATE 3 VAD MODULAR CABLE
Report
- Report Number
- 2916596-2022-10495
- Event Type
- Malfunction
- Date Received
- April 26, 2022
- Date of Event
- April 13, 2022
- Report Date
- June 10, 2022
- Manufacturer
- THORATEC CORPORATION
- Product Code
- DSQ
- UDI-DI
- 00813024013181
- PMA / PMN Number
- P160054
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AR, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.
MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULTS ACTIVE WAS CONFIRMED VIA THE ANALYSIS RETURNED MODULAR CABLE AND ANALYSIS OF THE LOG FILES. THE HEARTMATE 3 VAD MODULAR CABLE WAS RETURNED TO ABBOTT BURLINGTON, DURING THE EVALUATION, THE MODULAR CABLE WAS FUNCTIONALLY TESTED AND DID NOT PASS TESTING DUE TO DRIVELINE POWER FAULTS BEING ACTIVE WHEN CONNECTED TO A MOCK LOOP, CONFIRMING THE REPORTED EVENT. THE RETURNED MODULAR CABLE (LOT NUMBER 7880077) WAS THEN TESTED BY MEASURING THE RESISTANCE OF THE INDIVIDUAL WIRES USING A DIGITAL MULTIMETER AND THE BROWN (POWER A) WIRE MEASURED ELECTRICALLY OPEN, INDICATING CONDUCTOR BREAKDOWN IN THE WIRE. ADDITIONALLY, THE BLACK (GROUND A) WIRE AND THE RED (POWER B) WIRE HAD ELEVATED RESISTANCES THAT EXCEEDED 1 OHM. THE RETURNED MODULAR CABLE WAS THEN CONNECTED TO THE RETURNED CONTROLLER (HSC-101299) AND IMMEDIATELY A DRIVELINE POWER FAULT WAS ACTIVE. THE PUMP SPEED WAS NOT AFFECTED BY THE ALARM. THE POLYURETHANE JACKET WAS THEN DISSECTED TO REVEAL THAT ALL OF THE UNDERLYING WIRES WERE KINKED. ADDITIONALLY, THE BROWN (POWER A) WIRE WAS COMPLETELY SEVERED AND ELECTRICALLY SHORTING TO THE BLACK (GROUND A) WIRE WHICH CAUSED THE REPORTED EVENT OF DRIVELINE POWER ALARMS. ADDITIONALLY, LOG FILES WERE SUBMITTED FOR ANALYSIS AND DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER. THE SUBMITTED LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 11 DAYS (03APR2022 ¿ 14APR2022). THE LOG FILE CAPTURED A DRIVELINE POWER FAULT FROM 13APR2022 AT 21:36:53 TO THE LAST EVENT IN THE LOG FILE (14APR2022 AT 11:34:10) DUE TO A PWR_A_BROKEN FAULT. DURING THE DURATION OF THE ALARM BEING ACTIVE, PUMP SPEED WAS NOT AFFECTED. ADDITIONALLY, THE DOWNLOADED LOG FILE FROM THE RETURNED SYSTEM CONTROLLER CONTAINED DATA SPANNING APPROXIMATELY 2 HOURS ON 20APR2022 (11:35:51 ¿ 13:44:11). THE LOG FILE CAPTURED A DRIVELINE POWER FAULT FROM THE FIRST EVENT IN THE LOG FILE (20APR22022 AT 11:35:51) TO 20APR2022 AT 13:43:25 DUE TO A PWR_A_BROKEN FAULT. DURING THE DURATION OF THE ALARM BEING ACTIVE, PUMP SPEED WAS NOT AFFECTED. THE ALARM RESOLVED WHEN THE CONTROLLER WAS DISCONNECTED FROM THE DRIVELINE AND POWERED OFF AND WAS NOT ACTIVE WHEN THE CONTROLLER WAS RETURNED TO ABBOTT DURING PRELIMINARY TESTING. PROVIDED INFORMATION STATED THAT THE OLD CONTROLLER AND MODULAR CABLE ARE BEING RETURNED USING THE CS 164749. THE EVENT LOG FILE IS APPROXIMATELY 10 MINUTES IN DURATION AND SHOWS THE DL POWER FAULT DID NOT REOCCUR (AFTER EXCHANGE). THE REMAINDER OF THE LOG FILE IS UNREMARKABLE. THE ROOT CAUSE OF THE REPORTED EVENT WAS DUE TO DAMAGED UNDERLYING WIRES IN THE MODULAR CABLE THAT WERE ELECTRICALLY SHORTING TO ONE ANOTHER; HOWEVER, THE ROOT CAUSE OF THE DAMAGED WIRES COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE 3 VAD MODULAR CABLE (LOT#: 7880077) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. 7880077 WAS SHIPPED FROM ABBOTT ON 12MAY2021. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS INCLUDING DRIVELINE POWER FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE III INSTRUCTIONS FOR USE SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE AND ADVISES THE PATIENT NOT TO GET THEIR EQUIPMENT WET. HEARTMATE 3 LVAS IFU AND PATIENT HANDBOOK ARE CURRENTLY AVAILABLE. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE IN SECTION 4 ¿LIVING WITH THE HEARTMATE 3". IN SEVERAL SECTIONS, THIS DOCUMENT WARNS THE USER TO NEVER PUT THE DRIVELINE, SYSTEM CONTROLLER, OR ANY EXTERNAL EQUIPMENT INTO WATER OR LIQUID; IMMERSION IN WATER OR LIQUID MAY CAUSE THE PUMP TO STOP. SECTION 4 "LIVING WITH THE HEARTMATE 3" OF THE PATIENT HANDBOOK (UNDER "CARING FOR THE DRIVELINE") CONTAINS INFORMATION REGARDING HOW TO CLEAN AND CARE FOR THE DRIVELINE. THE PATIENT HANDBOOK CAUTIONS THE USERS TO CALL THEIR HOSPITAL CONTACTS IF THEY THINK, FOR ANY REASON, ANY PORTION OF THEIR EQUIPMENT IS NOT FUNCTIONING AS USUAL, IS BROKEN, OR THEY ARE UNCOMFORTABLE WITH THE OPERATION OF THE EQUIPMENT. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.
IT WAS REPORTED THAT THERE WAS A DRIVELINE FAULT ALARM THAT STARTED ON (B)(6) 2022. IT WAS NOTED THAT THERE WAS A NICKED AREA ON THE PATIENT SIDE OF THE MODULAR CABLE AND WAS THE ONLY AREA OF DAMAGE. LOG FILE ANALYSIS WAS PERFORMED AND CONFIRMED THERE WERE VISUAL AND AUDIBLE DRIVELINE POWER A FAULT ADVISORY ALARMS ON (B)(6) 2022 AT 21:36:53 WHICH WAS AN INDICATION OF AN INCREASE IN THE RESISTANCE ALONG THE PATH OF POWER A LINE. THE MODULAR CABLE AND SYSTEM CONTROLLER WERE EXCHANGED WHICH RESOLVED THE ALARMS. RELATED MANUFACTURER'S REFERENCE NUMBER FOR THE EXCHANGED SYSTEM CONTROLLER: 2916596-2022-10464.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1529683 | HEARTMATE 3 VAD MODULAR CABLE | VENTRICULAR (ASSIST) BYPASS | DSQ | THORATEC CORPORATION | 106525 | 00813024013181 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 26 YR | Female |