BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOWER MISTER WITH IV SETS

    MDR report key: 3915868 · Received June 12, 2014

    Report

    Report Number
    2242352-2014-00667
    Event Type
    Malfunction
    Date Received
    June 12, 2014
    Date of Event
    May 9, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MAQUET CARDIOVASCULAR LLC
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE DEVICE IS NOT AVAILABLE TO BE RETURNED TO US, A TECHNICAL EVALUATION CANNOT BE PERFORMED. PER OUR SOPS, ALL EVENTS ARE TRACKED AND TRENDED TO DETERMINE WHETHER OR NOT ANY TRENDS DEVELOP. THERE WAS NO NONCONFORMITY RECORDED IN THE LOT HISTORY WHICH WOULD BE CONSIDERED RELATED TO THE REPORTED EVENT. (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CLEAR TUBING WAS MISSING ON THE TIP OF THE BLOWER MISTER WITH IV SETS. A REPLACEMENT DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PATIENT EFFECTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    347539 BLOWER MISTER WITH IV SETS ENDOSCOPIC VESSEL HARVESTING GCJ MAQUET CARDIOVASCULAR LLC CB-1000 96255450

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR