BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PATIENT CONTROLLED EPIDURAL

    MDR report key: 7457787 · Received April 25, 2018

    Report

    Report Number
    7457787
    Event Type
    Malfunction
    Date Received
    April 25, 2018
    Date of Event
    November 27, 2017
    Report Date
    April 16, 2018
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT DELIVERED VIA C-SECTION ON [DATE REDACTED] AT 2024. PATIENT ARRIVED TO UNIT WITH PATIENT CONTROLLED EPIDURAL (PCE) MACHINE RUNNING. NO ALARM ALERTS NOTED ON PATIENT CONTROLLED EPIDURAL (PCE) MACHINE. AT 0200, NOTED THAT MEDICATION BAG IN PCE DID NOT SEEM TO HAVE A LESSENED ABOUT OF MEDICATION DESPITE MACHINE INFORMATION THAT MEDICATION WAS BEING ADMINISTERED. PATIENT PHYSICIAN CALLED AND REPLACED PCE WITH PATIENT CONTROLLED ANALGESIA (PCA) PUMP. UPON WASTING MEDICATION, 90ML NOTED LEFT IN MEDICATION BAG. PCE MACHINE SHOWED 80.2ML HAD BEEN ADMINISTERED TO THE PATIENT. PRIMED UNIT AT 1000ML AND UNABLE TO DUPLICATE PROBLEM CM3- CM CLOSED, UNABLE TO DUPLICATE THE PROBLEM, RETURNED TO SERVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    300021 PATIENT CONTROLLED EPIDURAL PUMP, INFUSION, PCA MEA QC10-2013

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR