BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 2011612 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01718
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED COMPLAINT FOR SEPARATED/LOOSE WAS NOT CONFIRMED. HOWEVER, VISUAL EXAMINATION OF THE UNIT FOUND THE RESERVOIR RUPTURED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. A TIER II CORRECTIVE AND PREVENTIVE ACTION (CAPA), IM-CAPA (B)(4) WAS OPENED TO INVESTIGATE THE ROOT CAUSES THAT LED TO THE RUPTURE CONDITION. A BATCH REVIEW WAS CONDUCTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION AND/OR SHOULD ANY ADDITIONAL INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE BALLOON OF ONE (1) HALF DAY INFUSOR DEVICE HAD BECOME "DETACHED AND THE SOLUTION LEAKED IN THE SPACE BETWEEN THE INNER BALLOON AND EXTERNAL CHAMBER OF THE PUMP." THIS WAS OBSERVED DURING SET-UP. ACCORDING TO THE REPORT, THE DEVICE WAS BEING FILLED WITH 2.0G OF DESFERRIOXAMINE IN 60ML OF 0.9% SODIUM CHLORIDE. THERE IS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HALF DAY INFUSOR, 5ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10J072

    Patients

    Seq Age Sex Outcome Treatment
    1 SODIUM CHLORIDE| DESFERRIOXAMINE