BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9705841 · Received February 13, 2020

    Report

    Report Number
    2916596-2020-00390
    Event Type
    Malfunction
    Date Received
    February 13, 2020
    Date of Event
    January 21, 2020
    Report Date
    April 27, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, 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 10 DAYS ((B)(6) 2020 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) 2020 AT 19:18 WHILE THE MPU WAS IN USE. THE ALARM APPEARED TO HAVE BEEN CAUSED BY A LOSS OF AC POWER, AS THE RSOC VALUES STEADILY DECREASED DURING THE EVENT. THE ALARM RESOLVED WHEN POWER WAS RESTORED TO THE SYSTEM. NO OTHER NOTABLE EVENTS WERE OBSERVED. THE MPU (SERIAL NUMBER (B)(6)) WAS NOT RETURNED FOR ANALYSIS. MULTIPLE ATTEMPTS AT RETRIEVING INFORMATION ABOUT THE CAUSE OF THE ALARM WERE MADE, AND NO RESPONSES WERE RECEIVED. THE ROOT CAUSE OF THE OBSERVED LOSS OF AC POWER WITHIN THE LOG FILE 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. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) # P060040; P160054. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE ANALYSIS OF THE LOG FILES MULTIPLE NO EXTERNAL POWER ALARMS WHILE ON THE MOBILE POWER UNIT (MPU) WERE OBSERVED. THIS WAS CAUSED BY POWER TO THE MPU BEING BRIEFLY INTERRUPTED. THIS MAY BE DUE TO THE POWER CORD COMING LOOSE FROM THE WALL OUTLET OR THE HOUSE LOSING POWER. PATIENT WAS DOING WELL AND SHOULD BE DISCONTINUED HOME SOON. NO FURTHER OR ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170735 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR Required Intervention