BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 4152476 · Received October 6, 2014

    Report

    Report Number
    1828100-2014-00815
    Event Type
    Malfunction
    Date Received
    October 6, 2014
    Date of Event
    September 12, 2014
    Report Date
    September 12, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE BATTERIES IN THE SYSTEM-1. THE FSR PERFORMED A RELEASE TEST AND WAITED FOR THE POWER MANAGER TO RESET TO 18.0 AH. THE UNIT OPERATED TO MANUFACTURER SPECIFICATIONS AND WAS RETURNED TO CLINICAL USE. THE SUSPECT BATTERIES WERE RETURNED TO THE MANUFACTURER FOR FURTHER EVALUATION. PER THE LABORATORY EVALUATION, THE BATTERIES WERE RECEIVED IN A SEVERELY DEPLETED CONDITION, THE BATTERIES MEASURED 2.0 AND 2.5 VDC. THE BATTERIES WERE INSTALLED ON (B)(4) 2012.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING NOTICE OF FIELD CORRECTION (NFC) ACTIVITIES, HE FOUND THE SYSTEM-1 WOULD NOT BOOT-UP ON BATTERY. THE SYSTEM IS A BACK-UP AND HAS NOT BEEN USED OR CHARGED IN MONTHS. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    622183 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (HEART LUNG CONSOLE) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1