BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17052128 · Received June 2, 2023

    Report

    Report Number
    2916596-2023-03054
    Event Type
    Malfunction
    Date Received
    June 2, 2023
    Date of Event
    May 15, 2023
    Report Date
    July 19, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS CONFIRMED VIA THE SUBMITTED LOG FILES; HOWEVER, IT WAS NOT REPRODUCED. A REVIEW OF THE SUBMITTED CONTROLLER EVENT LOG FILES SPANNED APPROXIMATELY 9 DAYS (20AUG2022, 11NOV2022, 14NOV2022, 17NOV2022, 05MAR2023, AND 15MAY2023 ¿ 18MAY2023 PER TIME STAMP). DATA PRIOR TO (B)(6) 2023 IS NOT RELEVANT TO THIS INVESTIGATION. THROUGHOUT THE ENTIRE LOG FILES, THE DRIVELINE POWER FAULT ALARM WAS ACTIVE WITHOUT AN ASSOCIATED POWER FAULT FLAG EXCEPT ON (B)(6) 2023 AT 10:15:06 WHEN A PWR_A_BROKEN FAULT FLAG WAS ACTIVE. THE ALARM REMAINED ACTIVE THROUGH THE REMAINDER OF THE LOGS AND DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. A REVIEW OF THE SUBMITTED NEW CONTROLLER EVENT LOG FILES AFTER THE CLEANING AND EXCHANGE SPANNED APPROXIMATELY 6 DAYS (B)(6) 2023 PER TIME STAMP). THE ALARM SEEMED TO RESOLVE UNTIL (B)(6) 2023 WHEN THE DRIVELINE POWER FAULT ALARM WAS ACTIVE WITHOUT AN ASSOCIATED POWER FAULT FLAG. THE ALARM DID NOT AFFECT THE CONTROLLER'S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE MOD CABLE, LOT 8842110, RETURNED FOR ANALYSIS IN UNREMARKABLE CONDITION. THE CABLE WAS FUNCTIONALLY TESTED WITH THE RETURNED CONTROLLER AND FOUND TO OPERATE AS INTENDED DURING ANALYSIS; NO ALARMS WERE PRODUCED. THE CABLES INTERNAL CONDUCTORS WERE ALSO TESTED, AND NO ANOMALIES WERE NOTED. ADDITIONAL INFORMATION PROVIDED INDICATED THAT CLEANING THE MOD CABLE CONNECTORS AND EXCHANGING THE CABLE AND CONTROLLER, RESOLVED THE ALARMS TEMPORARILY. FLUID INGRESS WAS REPORTED IN THE OTHER RETURNED MOD CABLE CONNECTORS AND WAS CONFIRMED. A ROOT CAUSE FOR THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS; HOWEVER, THE FLUID INGRESS FROM THE OTHER MOD CABLE COULD HAVE CONTRIBUTED TO THE ALARM. DEVICE HISTORY RECORD WAS REVIEWED AND SHOWED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT DRIVELINE FAULT ALARMS. THE HEARTMATE3 LVAS PATIENT HANDBOOK SECTION 10 ¿SAFETY CHECKLISTS¿ PROVIDES CHECKLISTS TO ASSIST THE PATIENT IN PERFORMING ROUTINE MAINTENANCE OF HEARTMATE3 LVAD, INCLUDING INSPECTING THE DRIVELINE CABLE FOR SIGNS OF DAMAGE AND ENSURING THAT THE MODULAR IN-LINE CONNECTOR IS SECURE AND THE CONNECTOR LOCKING NUT IS IN THE LOCKED POSITION. HEARTMATE 3 INSTRUCTIONS FOR USE SECTION 2-¿SYSTEM OPERATIONS¿ AND HEARTMATE 3 PATIENT HANDBOOK SECTION 2-¿HOW YOUR HEART PUMP WORKS¿ EXPLAIN THAT IF IT HAS BEEN DETERMINED THAT DAMAGE HAS BEEN DETECTED IN THE MODULAR CABLE, IT SHOULD BE REPLACED. THE IFU AND PATIENT HANDBOOK CONTAINS INFORMATION ON CARING FOR THE DRIVELINE AND PROPER SHOWERING METHODS 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. THIS SECTION INSTRUCTS THE USER: "KEEP YOUR DRIVELINE CLEAN. WIPE OFF ANY DIRT OR GRIME. IF THE DRIVELINE GETS DIRTY, USE A TOWEL WITH MILD DISH SOAP AND WARM WATER TO GENTLY CLEAN IT. NEVER SUBMERGE THE DRIVELINE OR OTHER SYSTEM COMPONENTS IN WATER OR LIQUID." NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT. SECTION E1: REPORTER EMAIL: (B)(6).

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBERS: 2916596-2023-02953 AND 2916596-2023-05032.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: (B)(4). IT WAS REPORTED THAT ON (B)(6)2023 THE PATIENT HAD CONTINUOUS LOW FLOW, LOW SPEED AND DRIVELINE POWER FAULT ALARMS. THEY ALSO EXPERIENCED SHORTNESS OF BREATH AND CHEST PAIN. THE PATIENT PRESENTED TO THE CLINIC AND X-RAYS WERE TAKEN OF THE PATIENT'S DRIVELINE WHICH CAME BACK UNREMARKABLE. THE SYSTEM CONTROLLER AND MODULAR CABLE WERE EXCHANGED, BUT THE DRIVELINE POWER FAULT ALARMS DID NOT RESOLVE. DURING THE EXCHANGE, CORROSION WAS FOUND ON THE PUMP SIDE OF THE MODULAR CABLE AS WELL AS THE PUMP CABLE CONNECTION POINTS. ON (B)(6) 2023, THE CORROSION AT THE PUMP CONNECTION OF THE DRIVELINE WAS CLEANED AND THE PATIENT WAS GIVEN ANOTHER NEW MODULAR CABLE AND SYSTEM CONTROLLER. THE CLEANING AND SECOND EQUIPMENT EXCHANGE ONLY TEMPORARILY RESOLVED THE ALARMS. ON (B)(6)2023, THE PATIENT CAME BACK TO THE CLINIC WITH RECURRING DRIVELINE FAULTS AS WELL AS LOW FLOWS. IT WAS NOTED THAT THE PATIENT WAS ASYMPTOMATIC AND THE ALARMS HAD NO AFFECT ON PUMP MOTOR FUNCTION. THE PATIENT'S LOW FLOWS WERE A RESULT OF THEIR POOR ADHERENCE TO MEDICATION, AND AS A RESULT, THEY WERE HYPERTENSIVE. THE PATIENT WAS DISCHARGED HOME WITH THEIR DRIVELINE POWER FAULT ALARMS SILENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1509312 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525US 8842110 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Unknown