BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2883086 · Received December 18, 2012

    Report

    Report Number
    1828100-2012-01605
    Event Type
    Malfunction
    Date Received
    December 18, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED COMPLAINT WAS CONFIRMED BY THE FIELD SERVICE REP (FSR). THE BATTERIES AND BATTERY CABLE WERE REPLACED AND THE UNIT OPERATED TO CLINICAL USE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE ON THIS COMPLAINT THAT WOULD ALTER THE FACTS AND/OR CONCLUSION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 1

    THE FIELD SERVICE REPRESENTATIVE (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, HE FOUND CORROSION ON ONE WIRE TERMINAL OF THE BATTERY CABLE. THE FSR SCRAPED OFF CORROSION ON THE CABLE. THERE WAS NO CORROSION ON THE BATTERY ITSELF. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1