BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE MOBILE POWER UNIT, NA

    MDR report key: 9523932 · Received December 27, 2019

    Report

    Report Number
    2916596-2019-05929
    Event Type
    Injury
    Date Received
    December 27, 2019
    Date of Event
    November 5, 2019
    Report Date
    March 9, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024010883
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H4: ADDITIONAL INFORMATION. MANUFACTURER'S INVESTIGATION CONCLUSION: THE REPORTED EVENT OF NO EXTERNAL POWER ALARMS ASSOCIATED WITH A LOSS OF POWER WHILE CONNECTED TO THE MPU WAS CONFIRMED VIA THE SUBMITTED LOG FILE. THE SUBMITTED LOG FILE CONTAINED APPROXIMATELY 37 DAYS OF DATA ((B)(6) 2019 ¿ (B)(6) 2019 PER THE TIMESTAMP). THE LOG FILE CAPTURED NO EXTERNAL POWER ALARMS DUE TO TEMPORARY LOSSES OF POWER WHILE CONNECTED TO THE MPU ON (B)(6) 2019 FROM 8:08:35 TO 8:08:36, (B)(6) 2019 FROM 12:21:47 TO 12:21:48, AND (B)(6) 2019 AT 8:21:00. THE ALARMS WERE RESOLVED WHEN POWER FROM THE MPU WAS RESTORED. THE LOG FILE ALSO CAPTURED SEVERAL NO EXTERNAL POWER ALARMS DUE TO BOTH SYSTEM CONTROLLER POWER CABLES BEING DISCONNECTED; THESE EVENTS ARE ADDRESSED VIA (B)(4). THE SYSTEM CONTROLLER BACKUP BATTERY SUPPLIED POWER TO THE SYSTEM WITHOUT ISSUE DURING ALL LOSSES OF EXTERNAL POWER. THE LOG FILE ALSO CAPTURED A REPLACE SYSTEM CONTROLLER ALARM ASSOCIATED WITH LCD FAULTS; THIS ALARM IS ADDRESSED VIA (B)(4). NO OTHER NOTABLE ALARMS WERE ACTIVE IN THE LOG FILE. THE PUMP MAINTAINED A SPEED ABOVE THE LOW SPEED LIMIT THROUGHOUT THE LOG FILE. MULTIPLE REQUESTS WERE MADE TO OBTAIN ADDITIONAL EVENT INFORMATION (INCLUDING IF THE CAUSE OF THE LOSS OF POWER WAS DETERMINED AND IF THE PATIENT HAS A LOCKING AC POWER CORD FOR THE MPU); HOWEVER, NO RESPONSE WAS RECEIVED. THE MPU WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS ANALYSIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: 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 THE PATIENT EXPERIENCED SEVERAL NO EXTERNAL POWER ALARMS. ADDITIONAL INFORMATION WAS REQUESTED BUT NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321145 HEARTMATE MOBILE POWER UNIT, NA VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 107754 00813024010883

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR