BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2265806 · Received September 6, 2011

    Report

    Report Number
    1828100-2011-02681
    Event Type
    Malfunction
    Date Received
    September 6, 2011
    Date of Event
    August 11, 2011
    Report Date
    September 2, 2011
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    DURING USE OF THE DEVICE FOR A NON-CLINICAL ACTIVITY, THE USER REPORTED THAT THE BATTERY WOULD NOT FULLY CHARGE. THE SYSTEM WAS CONNECTED TO A LIVE OUTLET AND ALLOWED TO CHARGE OVERNIGHT. THE BATTERY WAS CHECKED THE FOLLOWING DAY AND IT WAS AT 18.0 AH. SINCE THE EVENT OCCURRED DURING A NON-CLINICAL ACTIVITY, THERE WAS NO PATIENT INVOLVEMENT DURING THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 ROLLER PUMP DTQ TERUMO CARDIOVASCULAR SYSTEM CORP. 801763

    Patients

    Seq Age Sex Outcome Treatment
    1