BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2822687 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04296
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 15, 2012
    Report Date
    October 16, 2012
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED PHOTOGRAPHS OF THE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED VIA PHOTOGRAPHIC EVALUATION. THE RESERVOIR WAS OBSERVED TO HAVE RUPTURED IN A NON-FOOTED POSITION. THE ROOT CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE. NO ADDITIONAL OBSERVATION WAS NOTED FROM THE PHOTO. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE BATCH REVIEW REVEALED THAT ALL OF THE ACCEPTANCE CRITERIA WERE MET TO RELEASE THE LOT. THERE WERE NO NON-CONFORMANCES, FAILURES, REWORK, OR DEVIATIONS RELATED TO THE LOT. THERE WERE NO CHANGES TO SPECIFICATIONS, TEST METHODS, PROCESS, EQUIPMENT, OR RAW MATERIALS THAT COULD BE ASSOCIATED WITH THE REPORTED CONDITION. DUE TO CYTOSTATIC SOLUTION CONTAMINATION, THE DEVICE IS NOT AVAILABLE FOR EVALUATION. HOWEVER, PHOTOGRAPHS OF THE DEVICE HAVE BEEN PROVIDED. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF A PHOTO EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT AN INFUSOR HAD A RESERVOIR RUPTURE DURING FILLING. THE DEVICE WAS BEING FILLED WITH A SOLUTION CONTAINING 6000 MG FLUOROURACIL IN 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 12C037

    Patients

    Seq Age Sex Outcome Treatment
    1