BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2922083 · Received January 15, 2013

    Report

    Report Number
    1828100-2013-00002
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 21, 2012
    Report Date
    December 21, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEM CORP
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE SERVICE REPAIR TECHNICIAN (SRT) REMOVED THE GUT ASSEMBLY AND CHECKED FOR EVIDENCE OF LEAKAGE FROM THE GUT BEARING. THE BEARING WAS NOT LEAKING. HE CHECKED FOR EVIDENCE OF BEARING FLUID ON THE PULLEYS AND ENCODER RING AND NONE WAS FOUND. HE CLEANED THE REINSTALLED THE PULLEY AND ENCODER RING. HE INSTALLED A NEW DRIVE BELT AND COMPLETED THE PREVENTATIVE MAINTENANCE PROCEDURE. THE UNIT OPERATES TO MANUFACTURER'S SPECIFICATIONS AND WILL BE RETURNED TO CLINICAL USE. NO ADDITIONAL ACTION WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THERE WERE FOUR BELT SLIP ERRORS ON THE ROLLER PUMP. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22956 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEM CORP 816571

    Patients

    Seq Age Sex Outcome Treatment
    1