BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 VAD MODULAR CABLE

    MDR report key: 17819010 · Received September 26, 2023

    Report

    Report Number
    2916596-2023-07005
    Event Type
    Malfunction
    Date Received
    September 26, 2023
    Date of Event
    September 1, 2023
    Report Date
    November 15, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013181
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF DRIVELINE POWER FAULT ALARMS WAS UNABLE TO BE CONFIRMED. THE MODULAR CABLE (LOT NUMBER: 172450) WAS RETURNED IN UNREMARKABLE CONDITION. THE MODULAR CABLE WAS CONNECTED TO THE MANUFACTURING TEST AND PASSED. THE MODULAR CABLE WAS ALSO CONNECTED AND FUNCTIONALLY TESTED WITH A TEST HEARTMATE 3 SYSTEM CONTROLLER IN THE LABS AT ABBOTT AND WAS FOUND TO OPERATE AS INTENDED. THE MODULAR CABLE WAS ABLE TO OPERATE A MOCK LOOP FOR EXTENDED OPERATION WITH NO ALARMS ACTIVE. THE MODULAR CABLE WAS STRIPPED TO INSPECT THE CONDITION OF THE UNDERLYING LAYER AND NO PHYSICAL ANOMALIES WERE OBSERVED. NO ADDITIONAL TESTING WAS CONDUCTED. THE MODULAR CABLE FUNCTIONED AS INTENDED. ADDITIONAL INFORMATION PROVIDED ON 15SEP2023 STATED THAT THE ALARMS DID NOT REAPPEAR. THE ROOT CAUSE OF THE REPORTED EVENT WAS UNABLE TO BE CONCLUSIVELY DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORDS WERE REVIEWED FOR THE MODULAR CABLE (LOT NUMBER: 172450) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER. HEARTMATE III INSTRUCTIONS FOR USE (REV. G) SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK (REV. G) 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 (REV. G) SECTION 8 ENTITLED ¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE III PATIENT HANDBOOK (REV. G) SECTION 6 ENTITLED ¿CARING FOR THE EQUIPMENT¿ ADDRESSES HOW TO PROPERLY CARE FOR AND MAINTAIN THE EQUIPMENT FOR PROPER USE. 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.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2023 AT AROUND 6:30 THE PATIENT EXPERIENCED A DRIVELINE POWER FAULT ALARM ON THEIR CONTROLLER. THE PATIENT DECIDED TO EXCHANGE THEIR CONTROLLER. AFTER THE EXCHANGE, THE ALARM RESOLVED. HOWEVER, THE ALARM APPEARED AGAIN AT AROUND 11:30. THE PATIENT INFORMED THE HOSPITAL AND WAS ADMITTED. ON THE WAY TO THE HOSPITAL, THE PATIENT DISCONNECTED AND RECONNECTED THEIR DRIVELINE WHICH RESOLVED THE ALARM. AFTER THE SECOND EPISODE, NO FURTHER ALARMS APPEARED. THE PATIENT WAS TO STAY IN THE HOSPITAL FOR THE NEXT 48 HOURS FOR CLOSE MONITORING. IT WAS ALSO NOTED THAT THE PATIENT HAD SEVERAL DAMAGED AREAS ON THE OUTER LAYER OF THEIR DRIVELINE CLOSE TO THE DRIVELINE EXIT SITE WHICH HAD BEEN REPAIRED WITH RESCUE TAPE IN THE PAST. IT WAS LATER REPORTED THAT THE MODULAR CABLE WAS EXCHANGED. THE ALARM DID NOT REAPPEAR. THE PATIENT WAS STABLE AND DISCHARGED HOME. PUMP MFR # 2916596-2023-06617. FIRST CONTROLLER MFR # 2916596-2023-06691. SECOND CONTROLLER MFR # 2916596-2023-06692.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    985273 HEARTMATE 3 VAD MODULAR CABLE VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106525INT 00813024013181

    Patients

    Seq Age Sex Outcome Treatment
    1 Male