BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3162421 · Received June 6, 2013

    Report

    Report Number
    1828100-2013-00551
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 16, 2013
    Report Date
    May 16, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FIELD SERVICE REP (FSR) SUGGESTED TO HOSPITAL THAT THE ROLLER PUMP BE SWAPPED WITH SMALL ROLLER PUMP ON SYSTEM ONE IN STORAGE, WHILE THEY DECIDE WHETHER OR NOT TO SEND THE SUSPECT PUMP IN FOR EVAL. THE FIELD SERVICE REP (FSR) COMPLETED PREVENTATIVE MAINTENANCE SUCCESSFULLY AND THE SYSTEM OPERATED TO MFR SPECS AND WAS RETURNED TO CLINICAL USE.

    Description of Event or Problem · 1

    THE FIELD SERVICE REP (FSR) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE. THE SMALL ROLLER PUMP IN POSITION #1 DID NOT TURN SMOOTHLY, JERKS WHEN THE FSR USED A HAND CRANK AND THE PUMP WAS VERY LOUD DURING PULSE MODE. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250070 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801040

    Patients

    Seq Age Sex Outcome Treatment
    1