BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2962905 · Received February 15, 2013

    Report

    Report Number
    1416980-2013-03902
    Event Type
    Malfunction
    Date Received
    February 15, 2013
    Date of Event
    January 30, 2013
    Report Date
    January 30, 2013
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K071222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: BAXTER RECEIVED A PHOTO OF THE SAMPLE FOR EVALUATION. A REVIEW OF THE ATTACHED SAMPLE PHOTOS SHOWED EVIDENCE OF RESIDUAL FLUID INSIDE THE BLADDER AND FLOW WAS ALSO OBSERVED AT THE DISTAL LUER END OF THE INFUSOR SAMPLE. HOWEVER, DUE TO SAMPLE UNAVAILABILITY, A STANDARD FUNCTIONAL FLOW RATE TEST COULD NOT BE PERFORMED ON THE COMPLAINT SAMPLE IN ORDER TO VERIFY THE FLOW RATE OF THE INFUSOR DEVICE. THEREFORE, THE REPORTED UNDERINFUSION PROBLEM COULD NOT BE CONFIRMED. THE ROOT CAUSE COULD NOT BE DETERMINED. NO ADDITIONAL OBSERVATION WAS NOTED FROM THE PHOTO. NO REPAIR WAS DONE, AS THIS IS A SINGLE-USE DEVICE WHICH WILL BE DISCARDED 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

    THE HEALTH CARE PROFESSIONAL CONTACTED BAXTER (B)(4) WITH A REPORT THAT A 5 ML/HR INFUSOR UNDERINFUSED DURING PATIENT USE. THE PATIENT ARRIVED AT THE HOSPITAL WITH THE INFUSOR PRESENTING APPROXIMATELY 30% OF THE MEDICATION, AND THE MEDICATION SHOULD ALREADY HAVE BEEN COMPLETELY DELIVERED. THE CONCOMITANT MEDICAL PRODUCTS ARE CURRENTLY UNKNOWN. 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
    67392 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 12A003

    Patients

    Seq Age Sex Outcome Treatment
    1