BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 3812399 · Received May 15, 2014

    Report

    Report Number
    1416980-2014-15581
    Event Type
    Malfunction
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2014
    Report Date
    April 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BASAL/BOLUS INFUSOR WAS INVOLVED IN AN OVERINFUSION INCIDENT. THE REPORTER STATED THAT THE INFUSION WAS EXPECTED TO LAST TWO DAYS BUT ENDED IN ONE DAY. THE FILL VOLUME AND INVOLVED DRUG ARE UNKNOWN. IT IS UNKNOWN WHETHER THE PATIENT PRESSED THE MEDICATION DEMAND BUTTON OF AN ATTACHED PATIENT CONTROL MODULE (PCM) DURING THE INFUSION. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291960 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 PATIENT CONTROL MODULE (B)(4)