BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TERUMO ADVANCED PERFUSION SYSTEM 1

    MDR report key: 2935116 · Received January 14, 2013

    Report

    Report Number
    1828100-2013-00017
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    December 5, 2012
    Report Date
    December 20, 2012
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTQ
    PMA / PMN Number
    K022947
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL IS IN PROGRESS, BUT NOT YET CONCLUDED.

    Description of Event or Problem · 1

    THE SUBSIDIARY QUALITY ENGINEER REPORTED THAT DURING PREVENTATIVE MAINTENANCE (PM) OF THE DEVICE, THE CUSTOMER REPORTED THE ROLLER PUMP GUTS ROTATED ECCENTRICALLY. SINCE THE EVENT OCCURRED DURING PREVENTATIVE MAINTENANCE, THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21480 TERUMO ADVANCED PERFUSION SYSTEM 1 DTQ TERUMO CARDIOVASCULAR SYSTEMS CORP. 801041

    Patients

    Seq Age Sex Outcome Treatment
    1