BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLLOW FIER OXYGENATOR W/3000 ML

    MDR report key: 3020707 · Received March 18, 2013

    Report

    Report Number
    1124841-2013-00076
    Event Type
    Malfunction
    Date Received
    March 18, 2013
    Date of Event
    February 28, 2013
    Report Date
    February 28, 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 RECEIVED THE ACTUAL DEVICE FOR EVALUATION; HOWEVER, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO WILL BE 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 PRIOR TO CARDIOPULMONARY BYPASS SURGERY, DURING PRIME, THE CARDIOTOMY WAS CRACKED AND GAS (CARBON DIOXIDE) LEAKED. THERE WAS 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
    111654 HOLLOW FIER OXYGENATOR W/3000 ML BLOOD-GAS OXYGENATOR DTZ TERUMO CARDIOVASCULAR SYSTEMS CORP. 3CX*RX15RW30 PM29

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK