BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 15610118 · Received October 14, 2022

    Report

    Report Number
    2916596-2022-14490
    Event Type
    Malfunction
    Date Received
    October 14, 2022
    Date of Event
    September 13, 2022
    Report Date
    October 31, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURE¿S INVESTIGATION CONCLUSION: THE REPORTED EVENTS OF NO EXTERNAL POWER AND LOW VOLTAGE ALARMS WERE ABLE TO BE CONFIRMED. THE MOBILE POWER UNIT (MPU) (SERIAL NUMBER: (B)(6) WAS NOT RETURNED FOR ANALYSIS; HOWEVER, A LOG FILE WAS SUBMITTED FOR REVIEW (082442). A REVIEW OF THE SUBMITTED LOG FILES SHOWED EVENTS SPANNING APPROXIMATELY 41 DAYS (29AUG2022 ¿ 09OCT2022 PER TIMESTAMP). NO EXTERNAL POWER ALARMS COINCIDENT WITH LOSS OF AC POWER WERE ACTIVE ON 13SEP2022 FROM 13:28:45 ¿ 13:28:50, ON 20SEP2022 FROM 08:28:18 ¿ 08:30:31. THE ALARMS CLEARED ONCE POWER WAS RESTORED. THE BACKUP BATTERY WAS ABLE TO PROVIDE POWER TO THE SYSTEM DURING THE EVENTS. LOW VOLTAGE HAZARD ALARMS WERE ACTIVE ON 02OCT2022 FROM 16:34:33 ¿ 16:34:37 AND WERE CAUSED BY A LOSS OF AC POWER. THE BACKUP BATTERY WAS ACTIVATED AT THIS TIME AND WAS ABLE TO PROVIDE POWER TO THE PUMP. THE ALARMS CLEARED ONCE POWER WAS RESTORED. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. PUMP OPERATION AS NOT AFFECTED. ADDITIONAL INFORMATION PROVIDED ON 10OCT2022 STATED THAT THE THERE WAS A POWER OUTAGE AT THE HOME; HOWEVER, THE EXACT DATE OF THE EVENT IS UNKNOWN. IT IS UNKNOWN IF THE LOCKING MECHANISM IS AN ISSUE AS THE PATIENT DID NOT GO TO THE HOSPITAL WITH THE MPU. ADDITIONAL INFORMATION PROVIDED ON 24OCT2022 STATED THAT THE MPU HAS A V-LOCK CONNECTOR, THE AC POWER CORD DID NOT COME LOOSE FROM THE OUTLET NOR THE BACK OF THE UNIT AS THE ALARMS WERE CAUSED BY A LOSS OF AC POWER TO THE HOUSE. THE MPU WAS NOT EXCHANGED, AND NO PRODUCT WILL BE RETURNING. THE ROOT CAUSE OF THE REPORTED EVENT WAS CONCLUSIVELY DETERMINED TO BE CAUSED BY A POWER OUTAGE. HEARTMATE III INSTRUCTIONS FOR USE SECTION 7 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE III PATIENT HANDBOOK SECTION 5 ENTITLED ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING NO EXTERNAL POWER, POWER CABLE DISCONNECT, AND BACKUP BATTERY FAULT ALARMS. 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. THE DEVICE HISTORY RECORDS (WERE REVIEWED FOR THE MPU (SERIAL NUMBER: (B)(6) AND WAS FOUND TO PASS ALL MANUFACTURING AND QA SPECIFICATIONS BEFORE BEING SHIPPED TO THE CUSTOMER ON 30JUN2021. 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 IN SEPTEMBER AND EARLY OCTOBER 2022 THE PATIENT¿S HOUSE HAD LOST POWER, WHICH CAUSED THE MPU TO HAVE LOST POWER. THE PATIENT WAS NOT AFFECTED, AND THE DEVICE HAS REMAINED IN USE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT HAD NO EXTERNAL POWER ALARMS ON (B)(6) 2022 AND (B)(6) 2022 DUE TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED. IT WAS NOTED THAT THE PATIENT HAD LOST POWER TO THEIR HOUSE ONCE AROUND THE TIME ALARMS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2628621 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male