BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 15056446 · Received July 19, 2022

    Report

    Report Number
    2916596-2022-12226
    Event Type
    Malfunction
    Date Received
    July 19, 2022
    Date of Event
    June 3, 2022
    Report Date
    August 2, 2022
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER, LOW POWER HAZARD, AND POWER CABLE DISCONNECT ALARMS WERE CONFIRMED VIA LOG FILE ANALYSIS. A REVIEW OF SUBMITTED LOG FILE, EXTRACTED FROM THE PRIMARY CONTROLLER HSC-103463, CONTAINS DATA SPANNING APPROXIMATELY 7 DAYS ((B)(6) 2022 ¿ (B)(6) 2022, (B)(6) 2022 PER TIMESTAMP). ON (B)(6) 2022 AT 00:02:26, WHILE CONNECTED TO THE MOBILE POWER UNIT, LOW POWER HAZARD AND POWER CABLE DISCONNECT ALARMS ACTIVATED. THESE ALARMS TRANSITIONED INTO NO EXTERNAL POWER ALARMS AT 00:02:30 DUE TO BOTH BLACK AND WHITE LEAD VOLTAGES DIMINISHING FROM ~7.24 V TO ~0.01 V. THE BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM DUE TO THE SUDDEN LOSS OF AC POWER. THE DRIVELINE WAS DISCONNECTED AT 00:09:44 AND THE BACKUP BATTERY POWERED THE SYSTEM, WITH CONTINUED NO EXTERNAL POWER ALARMS, UNTIL THE CONTROLLER WAS SHUTDOWN AT 00:22:05. THE CONTROLLER WAS TURNED ON FROM 00:37:12 TO 00:45:04, WITH CONTINUED NO EXTERNAL POWER ALARMS, AND THE BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM. THERE WERE NO OTHER NOTABLE ALARMS ACTIVE IN THE LOG FILE. THE MOBILE POWER UNIT (MPU), SERIAL NUMBER UNKNOWN, WAS NOT RETURNED FOR ANALYSIS. PROVIDED INFORMATION STATED THAT THERE WAS A LOSS OF ELECTRICITY IN THE PATIENT¿S HOME. THERE WERE NO ADDITIONAL DOCUMENTS PROVIDED. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT; HOWEVER, NO RESPONSE WAS RECEIVED. A ROOT CAUSE FOR THE REPORTED NO EXTERNAL POWER, LOW POWER HAZARD, AND POWER CABLE DISCONNECT ALARMS WAS CONCLUSIVELY DETERMINED TO BE DUE TO THE REPORTED POWER OUTAGE IN THE PATIENT¿S HOME. HEARTMATE 3 INSTRUCTIONS FOR USE, REV. C, SECTION 7 ¿ ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE 3 PATIENT HANDBOOK, REV. D, SECTION 5 ¿ ¿ALARMS AND TROUBLESHOOTING¿ ADDRESSES HOW TO PROPERLY INTERPRET AND TROUBLESHOOT ALL SYSTEM ALARMS, INCLUDING LOW POWER HAZARD, NO EXTERNAL POWER, AND POWER CABLE DISCONNECT ALARMS. 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2916596-2022-11845; 2916596-2022-11847. IT WAS REPORTED THE PATIENT WAS FOUND UNRESPONSIVE FOLLOWING A LOSS OF ELECTRICITY AT HOME. POWER TO THE MOBILE POWER UNIT (MPU) WAS INTERRUPTED ON (B)(6) 2022 AT 0002:26. THE PATIENT'S LOG FILE CONTAINED LOW POWER HAZARD, NO EXTERNAL POWER, AND POWER CABLE DISCONNECT ALARMS WHILE POWER TO THE MPU WAS INTERRUPTED. THE EMERGENCY BACKUP BATTERY (EBB) BEGAN OPERATING THE SYSTEM ON (B)(6) 2022 AT 00002:27. THE EBB OPERATED THE SYSTEM UNTIL (B)(6) 2022 AT 0009:44 WHEN THE DRIVELINE WAS DISCONNECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1528291 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male