BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3212104 · Received July 8, 2013

    Report

    Report Number
    1416980-2013-17752
    Event Type
    Malfunction
    Date Received
    July 8, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED ONE SAMPLE FOR EVALUATION. THE CAUSE WAS DETERMINED TO BE A MANUFACTURING ISSUE, AS THERE WAS A HUMAN ERROR PRIOR TO ASSEMBLY OF THE STRESS MEMBER AND CAP SUBASSEMBLY. IN ORDER TO ADDRESS THIS ISSUE, AWARENESS TRAINING HAS BEEN PERFORMED FOR THE PERSONNEL. A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION; HOWEVER, THE EVALUATION IS NOT YET COMPLETED. VISUAL INSPECTION OBSERVED A CIRCULAR CRACK ON THE TOP AREA OF THE PURPLE COILED CAP. THE INITIAL INVESTIGATION CONFIRMED THE REPORTED CRACK CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INFUSOR LV10 DEVICE HAD A CRACKED COILED CAP. THIS WAS OBSERVED BEFORE USE. THERE WAS NO PATIENT INVOLVEMENT. ADDITIONAL INFORMATION WAS REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308829 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12K039

    Patients

    Seq Age Sex Outcome Treatment
    1