BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FX OXY W/HR & ART FILTER

    MDR report key: 4092740 · Received August 20, 2014

    Report

    Report Number
    9681834-2014-00236
    Event Type
    Malfunction
    Date Received
    August 20, 2014
    Date of Event
    August 5, 2014
    Report Date
    August 5, 2014
    Manufacturer
    TERUMO CORP, ASHITAKA
    Product Code
    DTZ
    PMA / PMN Number
    K130520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETED AND MORE INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO VASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS, DURING PRIME, THE SAMPLING MANIFOLD TUBING OF THE OXYGENATOR HAD A TEAR NEAR THE WHILE LUER CONNECTION. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING PRIME. THE PRODUCT WAS CHANGED OUT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500573 FX OXY W/HR & ART FILTER BLOOD GAS OXYGENATOR DTZ TERUMO CORP, ASHITAKA 1CX*FX15RW40 130808

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK