BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2232007 · Received September 1, 2011

    Report

    Report Number
    6000001-2011-22242
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 11, 2011
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, THIS PRODUCT IS BEING REPORTED BECAUSE IT IS SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. VISUAL EXAMINATION CONFIRMED THE REPORTED CONDITION OF A RUPTURED RESERVOIR. APPROXIMATELY 40 ML OF SOLUTION WAS ALSO NOTED IN THE HOUSING DUE TO THE RUPTURE. 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. THIS ISSUE IS BEING INVESTIGATED THROUGH CORRECTIVE AND PREVENTATIVE ACTION (CAPA).

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD A RESERVOIR RUPTURE BEFORE PATIENT CONNECTION. THE DEVICE WAS FILLED WITH A SOLUTION OF 5-FLUOROURACIL AND SALINE. THIS CONDITION HAS THE POTENTIAL TO INTERRUPT THERAPY. 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 11D008

    Patients

    Seq Age Sex Outcome Treatment
    1