BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2100362 · Received May 24, 2011

    Report

    Report Number
    6000001-2011-04451
    Event Type
    Malfunction
    Date Received
    May 24, 2011
    Date of Event
    May 3, 2011
    Report Date
    May 4, 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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF A RUPTURED RESERVOIR. AS A RESULT OF THE RUPTURE, APPROXIMATELY 50 ML OF SOLUTION COLLECTED IN THE HOUSING. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING DEFECT. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. PER REVIEW OF THE BATCH RECORDS, NO NONCONFORMANCE REPORT WAS DOCUMENTED FOR THIS LOT. ALL RELEASE CRITERIA WERE MET FOR THE BUILD OF THE LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    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

    BAXTER (B)(4) RECEIVED A COMPLAINT THAT ONE HALF DAY INFUSOR, 5ML/HR 12PK RUPTURED DURING FILLING WITH DESFERRIOXAMINE. THERE WAS NO REPORT OF PATIENT INVOLVEMENT, AS THIS OCCURED PRIOR TO PATIENT INJURY. NO MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION. THE SAMPLE IS AVAILABLE FOR EVALUATION. THIS WILL REFERENCE REPORT 1 OF 2 FOR THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K046

    Patients

    Seq Age Sex Outcome Treatment
    1