BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2200212 · Received August 11, 2011

    Report

    Report Number
    6000001-2011-17957
    Event Type
    Malfunction
    Date Received
    August 11, 2011
    Date of Event
    May 28, 2011
    Report Date
    June 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK AT THE JUNCTION OF THE TUBING AND THE LUER WAS CONFIRMED. UPON SAMPLE RECEIPT, THE DEVICE CONTAINED NO FLUID IN THE BLADDER. TO VERIFY THE REPORTED CONDITION, A LEAK TEST WAS PERFORMED ON THE SAMPLE. THE ROOT CAUSE WAS OPERATOR ERROR DURING THE MANUAL SOLVENT-BONDING APPLICATION PROCESS. AS A RESULT OF THIS INCIDENT, THE COMPLAINT SAMPLE WAS USED TO BRING AWARENESS TO ALL APPLICABLE MANUFACTURING OPERATORS. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RETURNED TO BAXTER AND IS CURRENTLY AWAITING EVALUATION. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL DETAILS BECOME AVAILABLE.

    Description of Event or Problem · 1

    BAXTER PERSONNEL REPORTED AN INFUSOR THAT LEAKED AT THE JUNCTION OF THE TUBING AND LUER LOCK. THIS CONDITION OCCURRED DURING EVALUATION. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY OR BREACH THE STERILE FLUID PATHWAY. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09G025

    Patients

    Seq Age Sex Outcome Treatment
    1