BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 2132136 · Received June 17, 2011

    Report

    Report Number
    6000001-2011-07905
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    December 13, 2010
    Report Date
    December 13, 2010
    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). ONE SAMPLE WAS RECEIVED CONTAINING FLUID IN THE BLADDER. TO VERIFY THE REPORTED CONDITION, THE FILL-PORT CAP WAS REMOVED. UPON REMOVAL, A BACK-FLOW WAS OBSERVED AT THE FILL-PORT. NO OTHER OBSERVATION WAS NOTED. THE SAMPLE WAS SUBSEQUENTLY DISASSEMBLED FOR EXAMINATION. AS A RESULT, A TINY GLASS FRAGMENT WAS FOUND UNDER THE CHECKBAND. NO OTHER CAUSE OF BACK-FLOW WAS FOUND DURING THE EXAMINATION. BASED ON THE FINDINGS, THE BACK-FLOW CONDITION WAS CAUSED BY A GLASS FRAGMENT INTRODUCED INTO THE FLUID PATHWAY DURING FILLING WITHOUT THE USE OF A FILTER. A BATCH REVIEW HAS BEEN PERFORMED AND THERE WERE NO NON-CONFORMANCES RELATED TO THE REPORTED CONDITION.

    Description of Event or Problem · 1

    BAXTER (B)(4) RECEIVED A REPORT THAT BACKFLOW WAS OBSERVED FROM THE FILLING PORT DURING FILLING. IT IS UNKNOWN WITH WHAT THE DEVICE WAS FILLED. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THE ACTUAL SAMPLE IS AVAILABLE. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10F002

    Patients

    Seq Age Sex Outcome Treatment
    1