BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3003111 · Received March 14, 2013

    Report

    Report Number
    1416980-2013-06089
    Event Type
    Malfunction
    Date Received
    March 14, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A RUPTURED RESERVOIR WAS CONFIRMED. VISUAL EXAMINATION OF THE UNIT DETERMINED THAT THE BLADDER RUPTURED IN A FOOTED POSITION. THE ROOT CAUSE WAS UNDETERMINED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Additional Manufacturer Narrative · 1

    (B)(4). INITIAL EVALUATION CONFIRMED THE REPORTED CONDITION. UPON COMPLETION OF BAXTER'S INVESTIGATION, A FOLLOW-UP WILL BE SUBMITTED. 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.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT OF AN INFUSOR THAT RUPTURED AT THE END OF PATIENT THERAPY. ACCORDING TO THE REPORTER, THE INFUSOR WAS FILLED WITH A NON-BAXTER PRODUCT. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION NECESSARY, OR ADVERSE REACTION IN ASSOCIATION WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107194 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12J041

    Patients

    Seq Age Sex Outcome Treatment
    1 FORTUM