BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 16230255 · Received January 23, 2023

    Report

    Report Number
    2916596-2023-00175
    Event Type
    Malfunction
    Date Received
    January 23, 2023
    Date of Event
    December 8, 2022
    Report Date
    January 26, 2024
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011286
    PMA / PMN Number
    P060040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    MANUFACTURE¿S INVESTIGATION CONCLUSION: THERE WERE INCIDENTAL FINDINGS OF A CUT IN THE BLACK POWER CABLE THAT LED TO A VISIBLE GREEN CONTAMINATE. THE HEARTMATE II CONTROLLER (SERIAL NUMBER (B)(4)) WAS RETURNED FOR EVALUATION FOLLOWING THE REPORTED EVENT OF DRIVELINE FAULT ALARMS ACTIVE. THE HEARTMATE II CONTROLLER WAS RETURNED AND EVALUATED AT ABBOTT. DURING THE EVALUATION, THE CONTROLLER WAS FUNCTIONALLY TESTED AND PASSED ALL STEPS WITHOUT ISSUE. ADDITIONALLY, THE CONTROLLER WAS CONNECTED TO A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME AND OPERATED A TEST PUMP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS ACTIVE. THE CONTROLLER OPERATED AS INTENDED DURING TESTING. ADDITIONALLY, THE DOWNLOADED LOG FILE FROM THE RETURNED CONTROLLER (LABELED BC160846) AND THE SUBMITTED LOG FILE FROM THE RETURNED CONTROLLER (LABELED BC121137) CONTAINED COMBINED DATA SPANNING APPROXIMATELY 10 DAYS (06DEC2022 ¿ 16DEC2022 PER THE TIMESTAMP). THE DRIVELINE WAS DISCONNECTED ON (B)(6) 2022 FROM 13:32:34 TO THE END OF THE LOG FILE; HOWEVER, THIS IS CONSISTENT WITH THE CONTROLLER BEING EXCHANGED. THE LOG FILE CAPTURED INTERMITTENT DRIVELINE FAULTS FROM (B)(6) 2022 AT 4:03:16 TO (B)(6) 2022 AT 9:32:50. THIS FAULT INDICATED AN ISSUE RELATING WITH PHASE 2. THE ALARMS APPEARED TO RESOLVE INTERMITTENTLY; HOWEVER, THEY WOULD REAPPEAR AGAIN THROUGHOUT THE LOG FILES. THE ALARMS DID NOT AFFECT THE PUMP SPEED. THE DRIVELINE FAULT ALARMS ARE ADDRESSED VIA THE PUMP INVESTIGATION (PI-2022-0193422-01) AS THE DRIVELINE FAULT ALARMS WERE DUE TO A DAMAGED WIRE IN THE DRIVELINE. THE REPORTED EVENT COULD NOT BE CORRELATED TO AN ISSUE WITH THE SYSTEM CONTROLLER AS THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE DUE TO A DAMAGED WIRE WITHIN THE DRIVELINE. HEARTMATE II INSTRUCTIONS FOR USE ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING DRIVELINE FAULT ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ISSUE DOES NOT RESOLVE. HEARTMATE II INSTRUCTIONS FOR USE SECTION 2 ENTITLED ¿SYSTEM OPERATIONS¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 2 ENTITLED ¿HOW YOUR HEART PUMP WORKS¿ STATES ¿DO NOT TWIST, KINK, OR SHARPLY BEND THE DRIVELINE, SYSTEM CONTROLLER POWER CABLES, POWER MODULE PATIENT CABLE, OR MOBILE POWER UNIT PATIENT CABLE, WHICH MAY CAUSE DAMAGE TO THE WIRES INSIDE, EVEN IF EXTERNAL DAMAGE IS NOT VISIBLE.¿ HEARTMATE II INSTRUCTIONS FOR USE SECTION 8-¿EQUIPMENT STORAGE AND CARE¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 6-¿CARING FOR THE EQUIPMENT¿ EXPLAIN HOW TO PROPERLY MAINTAIN THE INTEGRITY OF THE SYSTEM CONTROLLER. THE PATIENT HANDBOOK AND THE INSTRUCTIONS FOR USE CAUTION THE USER 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. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HEARTMATE II SYSTEM CONTROLLER (SERIAL#: (B)(4)) WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. (B)(4) WAS SHIPPED TO THE CUSTOMER ON (B)(6) 2018. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING DRIVELINE FAULT ALARMS TWENTY FIVE POWER CABLE DISCONNECT ALARMS WERE CREATED AS REQUESTED BY TECHNICAL SERVICES, THE SYSTEM CONTROLLER WAS EXCHANGED TO TROUBLESHOOT AUTHENTICITY OF ALARMS. LOG FILES NOTED NO ACTIVE ALARMS BUT THE PHASE DATA INDICATED THERE WAS AN ISSUE WITH THE BLACK WIRE IN DRIVELINE. RELATED MFR # 2916596-2022-15750.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    717242 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 6616086 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male