BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIBER OXY WITH 3000 ML

    MDR report key: 3042586 · Received April 4, 2013

    Report

    Report Number
    1124841-2013-00086
    Event Type
    Malfunction
    Date Received
    April 4, 2013
    Date of Event
    March 20, 2013
    Report Date
    March 20, 2013
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORP.
    Product Code
    DTZ
    PMA / PMN Number
    K051997
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE ACTUAL DEVICE FOR EVALUATION; THEREFORE, AN INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR SYSTEMS THAT PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING SETUP, A CRACK WAS NOTED AS THE BASE OF THE OUTLET ON TOP OF THE RESERVOIR. NO PATIENT INVOLVEMENT AS THIS OCCURRED DURING SETUP. PRODUCT WAS NOT USED. SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137832 HOLLOW FIBER OXY WITH 3000 ML BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX RX15RW30 PM29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK