BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 3800558 · Received February 11, 2014

    Report

    Report Number
    1828100-2014-00040
    Event Type
    Malfunction
    Date Received
    February 11, 2014
    Date of Event
    January 20, 2014
    Report Date
    January 20, 2014
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS 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) OBSERVED THE OCCLUSION KNOB TO BE OVER TIGHTENED. THE SRT REMOVED AND REINSERTED THE OCCLUSION KNOB RETAINING CLIP, WHICH RESTORED OCCLUSION KNOB FUNCTIONALITY. IF ADD'L INFO 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 SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING ROUTINE TESTING OF THE DEVICE AT THE SERVICE CENTER, THE OCCLUSION KNOB WAS FROZEN AND WOULD NOT MOVE ON THE SMALL ROLLER PUMP. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    90128 TERUMO ADVANCED PERFUSION SYSTEM 1 APS 1 (ROLLER PUMP) DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 816570

    Patients

    Seq Age Sex Outcome Treatment
    1