BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3061882 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09421
    Event Type
    Malfunction
    Date Received
    April 16, 2013
    Date of Event
    March 22, 2013
    Report Date
    March 26, 2013
    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). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE CONTAINING APPROXIMATELY 51 ML OF SOLUTION IN THE RESERVOIR. THE REPORTED CONDITION OF NON-DELIVERY WAS NOT CONFIRMED. VISUAL EXAMINATION OF THE DEVICE SHOWED NO SIGNS OF BLOCKAGE THAT COULD HAVE CAUSED THE REPORTED CONDITION. FLOW WAS READILY OBSERVED AT THE LUER. FLOW CONTINUED WITHOUT STOPPING UNTIL THE SOLUTION WAS EMPTIED FROM THE RESERVOIR. 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

    IT WAS REPORTED THAT AN INFUSOR HAD DELIVERY STOP DURING PATIENT USE. THE DEVICE WAS FILLED WITH A SOLUTION OF FOLFOX MEDICATION. FORCE PRIMING WAS SUCCESSFUL BEFORE THE INFUSOR WAS CONNECTED TO THE PATIENT. 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
    163939 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12H024

    Patients

    Seq Age Sex Outcome Treatment
    1 FOLFOX MEDICATION