BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3021987 · Received March 26, 2013

    Report

    Report Number
    1416980-2013-07317
    Event Type
    Malfunction
    Date Received
    March 26, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING NO SOLUTION IN THE RESERVOIR. THE REPORTED CONDITION OF NO FLOW/NON-DELIVERY WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED CONDITION. FUNCTIONAL TESTING DETERMINED THAT THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. NO ROOT CAUSE WAS IDENTIFIED, AS NO EVIDENCE OF PRODUCT MALFUNCTION WAS OBSERVED. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT. 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 STOPPED INFUSING DURING PATIENT THERAPY. WHEN THE PATIENT RETURNED TO THE HOSPITAL TO HAVE THE INFUSOR DISCONNECTED, IT WAS NOTED THAT APPROXIMATELY 50-60ML OF FLUID LEFT IN THE DEVICE. THE HOSPITAL DID NOT OBSERVE ANY FLOW FROM THE PRODUCT AFTER IT WAS DISCONNECTED FROM THE PATIENT. 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
    123025 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12K037

    Patients

    Seq Age Sex Outcome Treatment
    1 FLUOROURACIL