BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE II SYSTEM CONTROLLER

    MDR report key: 17202354 · Received June 26, 2023

    Report

    Report Number
    2916596-2023-03454
    Event Type
    Malfunction
    Date Received
    June 26, 2023
    Date of Event
    May 29, 2022
    Report Date
    June 26, 2023
    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
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE SERIAL NUMBER REQUESTED BUT NOT PROVIDED. VOLUNTARY MW NUMBER 3400300000-2022-0000022 WAS RECEIVED 30MAY2023 MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED VIA THE LOG FILE REVIEW. THE LOG FILE SPANNED APPROXIMATELY 8 DAYS ((B)(6) 2022 TO (B)(6) 2022 PER THE TIMESTAMP). A NO EXTERNAL POWER ALARM COINCIDED WITH A PUMP STOP AND ACTIVATED ON (B)(6) 2022 AT 22:30 DUE TO SIMULTANEOUSLY DISCONNECTING THE POWER CABLES. THE BACKUP BATTERY WAS ABLE TO PROVIDE POWER TO THE PUMP DURING THE ALARM. THE ALARM RESOLVED SHORTLY AFTER RECONNECTING TO A POWER SOURCE. THE ALARM MAY BE ASSOCIATED WITH A DRIVELINE DAMAGE THAT LEAD TO A PUMP STOP. NO OTHER NOTABLE ALARM WAS OBSERVED. THE HM2 SYSTEM CONTROLLER WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. ADDITIONAL INFORMATION PROVIDED ON 30MAY2023 STATED THAT A CONTROLLER EXCHANGE TOOK PLACE ON (B)(6) 2022. THERE WERE NO REPORTED ISSUES REGARDING THE FUNCTIONALITY OF THE SYSTEM CONTROLLER AT THE TIME OF THE EXCHANGE. THE EXCHANGE OCCURRED IN THE SAME HOSPITAL VISIT AS THE REPORTED PUMP EXCHANGE THAT OCCURRED ON (B)(6) 2022; HOWEVER, THE CONTROLLER EXCHANGE TOOK PLACE SEVERAL DAYS PRIOR TO THE PUMP EXCHANGE. MULTIPLE GOOD FAITH EFFORT ATTEMPTS WERE MADE ASKING FOR THE SERIAL NUMBER OF THE SYSTEM CONTROLLER, THE REASON FOR THE EXCHANGE, AND IF THE CONTROLLER WILL BE RETURNING; HOWEVER, NO RESPONSE WAS RECEIVED. THE ROOT CAUSE FOR THE REPORTED EVENT WAS UNABLE TO BE DETERMINED THROUGH THIS INVESTIGATION. THE DEVICE HISTORY RECORD CANNOT BE REVIEWED AS THE SERIAL/LOT NUMBER OF THE DEVICE WAS NOT AVAILABLE. 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 II INSTRUCTIONS FOR USE SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 3 ENTITLED ¿POWERING THE SYSTEM¿ ADDRESSES HOW TO PROPERLY SWITCH BETWEEN POWER SOURCES. HEARTMATE II INSTRUCTIONS FOR USE SECTION 7-¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II PATIENT HANDBOOK SECTION 5-¿ALARMS AND TROUBLESHOOTING¿ EXPLAIN HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALARMS INCLUDING NO EXTERNAL POWER. 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 ADMITTED ON (B)(6) 2022 WITH LEFT VENTRICULAR ASSIST (LVAD) ALARMS INCLUDING LOW BATTERY, CALL HOSPITAL, LOW FLOW, AND LOW VOLTAGE WITH THE DEVICE STOPPED FOR UP TO 9 MINUTES. ON (B)(6) 2022 A CONTROLLER EXCHANGE WAS PERFORMED. RELATED MFR: 2916596-2022-11436.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1453019 HEARTMATE II SYSTEM CONTROLLER VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106762 00813024011286

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Male