BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR

    MDR report key: 4093279 · Received September 16, 2014

    Report

    Report Number
    1416980-2014-31500
    Event Type
    Malfunction
    Date Received
    September 16, 2014
    Report Date
    August 22, 2014
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    FRN
    PMA / PMN Number
    K853881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    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 AN INFUSOR PATIENT CONTROL MODULE (PCM) WATCH HAD A PARTIALLY DETACHED BUTTON. THE REPORTER STATED THAT AFTER REMOVING THE SECURING CLIP, THE SPRING TENSION UNDER THE BUTTON CAUSED THE BACK-PLATE TO PARTIALLY DETACH FROM THE BODY. THE REPORTER STATED THAT THIS RESULTED IN AN OVERINFUSION OF MORPHINE, AS THIS DEFECT CAUSED A CONSTANT INFUSION OF THE DRUG EVEN THOUGH THE BUTTON WAS NOT PRESSED. AS SOON AS THE OVERINFUSION WAS IDENTIFIED, THE DEVICE WAS DISCONNECTED FROM THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 2.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    570867 INFUSOR PUMP, INFUSION FRN BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1 MORPHINE