BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 SYSTEM CONTROLLER

    MDR report key: 10188179 · Received June 24, 2020

    Report

    Report Number
    2916596-2020-02891
    Event Type
    Malfunction
    Date Received
    June 24, 2020
    Date of Event
    May 31, 2020
    Report Date
    September 22, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT OF THE SYSTEM CONTROLLER NOT STARTING THE PUMP WAS CONFIRMED VIA ANALYSIS OF THE LOG FILE DOWNLOADED FROM THE RETURNED SYSTEM CONTROLLER (SERIAL NUMBER: (B)(6)) AND VIA EVALUATION OF THE CONTROLLER. THE DOWNLOADED LOG FILE CONTAINED APPROXIMATELY 29 DAYS OF DATA ((B)(6) 2020 ¿ (B)(6) 2020 PER THE TIMESTAMP). THE LOG FILE CAPTURED EVENTS CONSISTENT WITH THE PUMP BEING EXPLANTED ON (B)(6) 2020, INCLUDING THE FIXED SPEED BEING DECREASED TO 3000 RPM FOLLOWED BY AN INTENTIONAL PUMP STOP. PRIOR TO THE INITIAL INTENTIONAL PUMP STOP, THE PUMP MAINTAINED A SPEED ABOVE OR EQUAL TO THE LOW SPEED LIMIT WITHOUT ISSUE. APPROXIMATELY 1 MINUTE AFTER THE INTENTIONAL PUMP STOP, A CONTROLLER FAULT ALARM ASSOCIATED WITH FUSES A AND B BEING OPEN ACTIVATED; THIS IS CONSISTENT WITH THE DRIVELINE BEING CUT DURING THE EXPLANT PROCEDURE. THE CONTROLLER FAULT ALARM WAS ACTIVE FOR THE REMAINDER OF THE LOG FILE. THE CONTROLLER WAS THEN PUT INTO SLEEP MODE APPROXIMATELY 5 MINUTES LATER AND WAS NOT POWERED ON AGAIN UNTIL (B)(6) 2020 AT 11:55:16. THE DRIVELINE WAS THEN CONNECTED AT 11:56:21; PUMP OFF AND LOW FLOW ALARMS ACTIVATED AT THIS TIME AS THE PUMP DID NOT START DUE TO FUSES A AND B BEING OPEN. THE DRIVELINE AND EXTERNAL POWER WERE THEN DISCONNECTED, AND THE CONTROLLER WAS PUT INTO SLEEP MODE ON (B)(6) 2020 AT 12:13:36. THE DRIVELINE WAS NOT RECONNECTED TO THE CONTROLLER. ADDITIONAL PROVIDED INFORMATION STATED THAT THE SYSTEM CONTROLLER WAS REUSED AND WAS PREVIOUSLY ASSIGNED TO A DIFFERENT PATIENT, WHO UNDERWENT A ROUTINE TRANSPLANT ON (B)(6) 2020; THIS IS CONSISTENT WITH THE DATA CAPTURED IN THE LOG FILE. IT WAS ALSO STATED THAT THE HOSPITAL IS AWARE THAT, PER THE INSTRUCTIONS FOR USE, THE SYSTEM CONTROLLER IS NOT SUPPOSED TO BE REUSED. THE RETURNED SYSTEM CONTROLLER WAS DISASSEMBLED TO INSPECT THE INTERNAL COMPONENTS REVEALING THAT BOTH FUSES A AND B WERE DAMAGED. THE DAMAGED FUSES WERE REPLACED WITH NEW FUSES. AFTER REPLACING THE FUSES, THE CONTROLLER PASSED FUNCTIONAL TESTING AND SUCCESSFULLY OPERATED IN A MOCK CIRCULATORY LOOP FOR AN EXTENDED PERIOD OF TIME WITHOUT ANY ISSUES OR ATYPICAL ALARMS PRODUCED. THE SYSTEM CONTROLLER FUNCTIONED AS INTENDED AFTER THE FUSES WERE REPLACED. THE ROOT CAUSE OF THE REPORTED EVENT WAS DETERMINED TO BE COMPROMISED FUSES DUE TO THE DRIVELINE BEING CUT DURING A ROUTINE TRANSPLANT ON A DIFFERENT PATIENT. THE HEARTMATE 3 INSTRUCTIONS FOR USE (IFU) EXPLAINS THAT ALL COMPONENTS OF THE HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM THAT ARE SUPPLIED STERILE ARE INTENDED FOR SINGLE USE ONLY. THE IFU STATES THAT ALL COMPONENTS, INCLUDING THE SYSTEM CONTROLLER, SHOULD NOT BE RE-USED OR RE-STERILIZED. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THE RECORDS REVEALED THE HM3 SYSTEM CONTROLLER, SERIAL NUMBER (B)(6), WAS MANUFACTURED IN ACCORDANCE WITH MANUFACTURING AND QA SPECIFICATIONS. INCIDENTAL FINDING: DIM PUMP RUNNING LEDS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: "LOW INTERNAL BATTERY" REFERRED TO THE BATTERY BEING CLOSE TO THE EXPIRATION DATE. NO ALARMS WERE REPORTED. THERE WAS NO REPORTED DIFFICULTY CONNECTING THE MOD CABLE AND CONTROLLER. IT WAS REPORTED THAT THIS SYSTEM CONTROLLER HAD BEEN USED BY ANOTHER PATIENT PREVIOUSLY. THE HOSPITAL IS AWARE THAT REUSE OF SYSTEM CONTROLLERS IS AGAINST THE INSTRUCTIONS FOR USE (IFU); HOWEVER, THEY REPORTEDLY DO SO OFTEN.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. THE PATIENT REMAINS ONGOING ON LVAS SUPPORT WITH A REPLACEMENT SYSTEM CONTROLLER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS CONCLUDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM CONTROLLER ALARMED FOR LOW INTERNAL BATTERY. IT WAS DECIDED TO EXCHANGE THE SYSTEM CONTROLLER WITH THE PATIENT'S BACKUP SYSTEM CONTROLLER. THE BACKUP SYSTEM CONTROLLER DID NOT START PROPERLY, WHICH REPORTEDLY LED TO A PUMP STOP. THE SYSTEM CONTROLLER WAS EXCHANGED AGAIN, BACK TO THE PRIMARY SYSTEM CONTROLLER, AND THE PUMP STARTED AGAIN. THE INTERNAL BATTERY IN THE PRIMARY SYSTEM CONTROLLER WAS THEN EXCHANGED, AND NO FURTHER ALARMS HAVE BEEN SEEN SINCE. THE PATIENT WAS REPORTED TO BE DOING FINE. THIS REPORT ADDRESSES THE BACKUP SYSTEM CONTROLLER, HSC-030947. MFR. #2916596-2020-03241 ADDRESSES THE PRIMARY SYSTEM CONTROLLER, HSC-010702.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651482 HEARTMATE 3 SYSTEM CONTROLLER VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106531INT 6677903

    Patients

    Seq Age Sex Outcome Treatment
    1