BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 10566509 · Received September 22, 2020

    Report

    Report Number
    2916596-2020-04529
    Event Type
    Injury
    Date Received
    September 22, 2020
    Date of Event
    September 5, 2020
    Report Date
    December 4, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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 SUBMITTED LOG FILES. THE SUBMITTED LOG FILES CONTAINED APPROXIMATELY 37 DAYS OF DATA COMBINED (03AUG2020 ¿ 09SEP2020 PER THE TIMESTAMP). THE LOG FILES CAPTURED A NO EXTERNAL POWER ALARM ON 05SEP2020 AT 16:50:29 DUE TO A TEMPORARY LOSS OF POWER WHILE CONNECTED TO THE MOBILE POWER UNIT (MPU). THE ALARMS WERE RESOLVED WHEN POWER TO THE MPU WAS RESTORED. THE SYSTEM CONTROLLER BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM DURING THE LOSS OF EXTERNAL POWER. THE ALARM DID NOT AFFECT THE CONTROLLER¿S ABILITY TO OPERATE THE PUMP AT THE SET SPEED. NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILES. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. HEARTMATE II PATIENT HANDBOOK, UNDER SECTION 5 ¿ALARMS AND TROUBLESHOOTING¿ AND HEARTMATE II INSTRUCTIONS FOR USE (IFU), UNDER SECTION 7 ¿ALARMS AND TROUBLESHOOTING¿ COVER ALL ALARMS (VISUAL AND AUDIBLE), INCLUDING THE NO EXTERNAL POWER AND LOW VOLTAGE HAZARD ALARM CONDITIONS, AND THE ACTIONS TO TAKE IF THE ALARMS CANNOT BE RESOLVED. HEARTMATE II INSTRUCTIONS FOR USE (IFU) UNDER SECTION 3 ¿POWERING THE SYSTEM¿ EXPLAINS THE VARIOUS WAYS TO POWER THE HEARTMATE II LVAS, INCLUDING HOW TO USE THE MPU AND THE ACTIONS TO TAKE IN THE EVENT OF A POWER FAILURE. HEARTMATE II PATIENT HANDBOOK AND HEARTMATE II INSTRUCTIONS FOR USE (IFU) CAUTION 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

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

    Description of Event or Problem · 1

    THE SUBMITTED LOG FILES CAPTURED A NO EXTERNAL POWER EVENT WHICH WAS CAUSED BY POWER TO THE MOBILE POWER UNIT (MPU) BEING BRIEFLY INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1030802 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other