BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 11581220 · Received March 29, 2021

    Report

    Report Number
    2916596-2021-01230
    Event Type
    Malfunction
    Date Received
    March 29, 2021
    Date of Event
    February 28, 2021
    Report Date
    May 11, 2021
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF A NO EXTERNAL POWER ALARM WAS CONFIRMED VIA THE PROVIDED LOG FILE. THE LOG FILE CONTAINED DATA SPANNING APPROXIMATELY 3 DAYS ((B)(6) 2021 PER TIME STAMP). THE PUMP MAINTAINED SPEEDS ABOVE THE LOW SPEED LIMIT WHILE CONNECTED TO THE DRIVELINE. A NO EXTERNAL POWER ALARM WAS OBSERVED ON (B)(6) 2021 AT 7:45 WHILE THE MPU WAS IN USE. THE ALARM APPEARED TO HAVE BEEN CAUSED BY A LOSS OF AC POWER, AS THE RSOC WAS OBSERVED TO STEADILY DECREASE WHICH ALSO TRIGGERED LOW VOLTAGE ALARMS LEADING UP TO THE NO EXTERNAL POWER EVENT. THE ALARM RESOLVED WITHIN THE SAME MINUTE OF ACTIVATION WHEN POWER WAS RESTORED TO THE SYSTEM. THE MPU WAS NOT RETURNED FOR ANALYSIS. QUESTIONS REGARDING THE MPU AND THE CAUSE OF THE EVENT WERE ASKED MULTIPLE TIMES AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE OBSERVED LOSS OF AC POWER WAS UNABLE TO BE DETERMINED THROUGH THIS ANALYSIS. HEARTMATE 3 PATIENT HANDBOOK WITH MPU DESCRIBES ALL ALARMS (VISUAL AND AUDIBLE) AND WHAT ACTION SHOULD BE PERFORMED WHEN THEY DO OCCUR, INCLUDING THE NO EXTERNAL POWER ALARM: TO RESOLVE THE NO EXTERNAL POWER ALARM: 1. IMMEDIATELY CONNECT THE SYSTEM CONTROLLER POWER CABLES TO A WORKING POWER SOURCE (FUNCTIONING MOBILE POWER UNIT OR TWO FULLY-CHARGED HEARTMATE 14 VOLT LITHIUM-ION BATTERIES). 2. CALL YOUR HOSPITAL CONTACT IMMEDIATELY IF CONNECTING TO POWER DOES NOT RESOLVE THE ALARM. HEARTMATE 3 INSTRUCTIONS FOR USE AND HEARTMATE 3 PATIENT HANDBOOK BOTH CAUTION 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 SERIAL NUMBER OF THE MPU WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: P060040; P160054.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS SEEN IN THE CLINIC. THE VAD COORDINATOR NOTED LOW VOLTAGE AND NO EXTERNAL POWER ALARMS. THE PATIENT'S LOG FILES WERE REVIEWED BY TECHNICAL SERVICES. THE LOG CAPTURED A SERIES OF LOW POWER/NO EXTERNAL POWER EVENTS ON (B)(6) 2021. THESE WERE CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED. THE LOG FILES INDICATE THAT THE PATIENT HAD NOT CONSISTENTLY BEEN CONNECTING TO THE MPU SUGGESTING THEY ARE SLEEPING ON BATTERIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479531 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR