BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3020240 · Received March 25, 2013

    Report

    Report Number
    1416980-2013-07186
    Event Type
    Malfunction
    Date Received
    March 25, 2013
    Date of Event
    January 29, 2013
    Report Date
    February 26, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    PHARMACIST

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE REPORTED CONDITION OF A LEAK WAS CONFIRMED. UPON SAMPLE RECEIPT, THE DEVICE CONTAINED APPROXIMATELY 50 ML OF FLUID IN THE RESERVOIR. TO VERIFY THE REPORTED CONDITION, THE FILL-PORT CAP WAS REMOVED. UPON REMOVAL, LEAKAGE (BACKFLOW) WAS OBSERVED COMING OUT OF THE FILL PORT. VISUAL EXAMINATION OF THE DISASSEMBLED UNIT REVEALED THE ROOT CAUSE OF THE LEAK WAS A 0.25-MM PARTICLE OF ACRYLIC RESIN BENEATH THE CHECK BAND. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED. NO OTHER OBSERVATIONS WERE NOTED ON THE UNIT.

    Description of Event or Problem · 1

    BAXTER PORTUGAL RECEIVED A REPORT OF AN INFUSOR THAT HAD LEAKED, FROM THE FILLPORT, PRIOR TO USE. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. THERE WAS NO PATIENT INVOLVEMENT; THEREFORE, NO PATIENT INJURY, MEDICAL INTERVENTION, NOR ADVERSE REACTION IS ASSOCIATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121488 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12A047

    Patients

    Seq Age Sex Outcome Treatment
    1