BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 1904879 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05045
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 21, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982012
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "RUPTURED RESERVOIR" WAS CONFIRMED. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE WILL BE IDENTIFIED/ADDRESSED THROUGH THE CAPA INVESTIGATION, (B)(4). A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4).ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) HALF DAY INFUSOR HAD RUPTURED DURING FILLING WITH DESFERRIOXAMINE. NO PATIENT INJURY OR MEDICAL INTERVENTION HAS BEEN REPORTED BY THE CUSTOMER; 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 10G003

    Patients

    Seq Age Sex Outcome Treatment
    1