BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2891009 · Received December 20, 2012

    Report

    Report Number
    1828100-2012-01616
    Event Type
    Malfunction
    Date Received
    December 20, 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
    BE
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE SERVICE REPAIR TECHNICIAN (SRT) REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE AT THE SUBSIDIARY'S SERVICE CENTER, THE SRT OBSERVED A LOOSE CONNECTION ON A WIRE (B)(4). SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP 802100

    Patients

    Seq Age Sex Outcome Treatment
    1