BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLOWER MISTER WITH IV SETS

    MDR report key: 2193004 · Received July 21, 2011

    Report

    Report Number
    2242352-2011-00985
    Event Type
    Malfunction
    Date Received
    July 21, 2011
    Date of Event
    June 27, 2011
    Report Date
    June 29, 2011
    Manufacturer
    MAQUET CARDIOVASCULAR, LLC
    Product Code
    GCJ
    PMA / PMN Number
    K030512
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO MAQUET CARDIAC SURGERY FOR INVESTIGATION. WE WILL CONTINUE PURSUING THE DEVICE BEING RETURNED BY THE CUSTOMER. A SUPPLEMENTAL REPORT WILL BE SUBMITTED IF THE DEVICE IS RECEIVED AND THE INVESTIGATION IS COMPLETED. INTERNAL FILE NUMBER - (B)(4).

    Description of Event or Problem · 1

    THE HOSPITAL REPORTED THAT DURING A CORONARY ARTERY BYPASS PROCEDURE, THE CB-1000 CO2 BACKED UP THROUGH THE DEVICE AND INTO THE IV BAG. THE REPORTER STATED THAT AFTER APPROX 30 MINS, A LOUD SOUND WAS HEARD CAUSED BY THE RUPTURE OF THE SALINE BAG. THE RUPTURED BAG CAUSED TO LIQUID TO RELEASE. A REPLACEMENT UNIT WAS USED TO COMPLETE THE PROCEDURE. THE HOSPITAL DID NOT REPORT ANY PT EFFECTS. THE PRODUCT IS RETURNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BLOWER MISTER WITH IV SETS CLAMPLESS BEATING HEART GCJ MAQUET CARDIOVASCULAR, LLC CB-1000 96255348

    Patients

    Seq Age Sex Outcome Treatment
    1 NA