BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2133314 · Received June 20, 2011

    Report

    Report Number
    6000001-2011-08057
    Event Type
    Malfunction
    Date Received
    June 20, 2011
    Date of Event
    June 2, 2011
    Report Date
    June 3, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: PER THE CUSTOMER, THIS DEVICE IS NOT AVAILABLE FOR EVALUATION. THEREFORE, THE RESULTS OF EVALUATION COULD NOT BE COMPLETED AND THE REPORTED CONDITION COULD NOT BE CONFIRMED. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. A BATCH REVIEW WAS CONDUCTED WHICH FOUND NO NONCONFORMANCES. 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 A TIER II CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: REPORTED CONDITION FOR RUPTURE CANNOT BE CONFIRMED SINCE NO PICTURE OR SAMPLE WAS AVAILABLE FOR EVALUATION. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. TIER II CORRECTIVE AND PREVENTIVE ACTION (CAPA), (B)(4) WAS OPENED TO INVESTIGATE THE ROOT CAUSES THAT LED TO THIS FAILURE MODE. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT ONE (1) INFUSOR RUPTURED DURING INFUSION. ACCORDING TO THE REPORTER, THE PATIENT OBSERVED THAT THE INFUSOR STOPPED FLOWING AND WAS PRESENTING AN UNUSUAL ASPECT. THE PATIENT WENT TO THE HOSPITAL WHERE IT WAS CONFIRMED A BLADDER RUPTURE, AND ABOUT 50% OF THE SOLUTION WAS REMAINING IN THE HOUSING OF THE INFUSOR. IT IS UNKNOWN WITH WHAT THE DEVICE WAS FILLED. NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10K065

    Patients

    Seq Age Sex Outcome Treatment
    1