BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALF DAY INFUSOR, 5ML/HR 12PK

    MDR report key: 1935041 · Received December 22, 2010

    Report

    Report Number
    6000001-2010-06096
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 26, 2010
    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). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT THE RESERVOIR OF ONE (1) HALF DAY INFUSOR, 5ML/HR DEVICE HAD RUPTURED AFTER FILLING. ACCORDING TO THE REPORT, THE DEVICE WAS FILLED WITH DESFERAL AND WATER. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. 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 10C102

    Patients

    Seq Age Sex Outcome Treatment
    1 WATER| DESFERAL