BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT

    MDR report key: 11338690 · Received February 17, 2021

    Report

    Report Number
    9610825-2021-00034
    Event Type
    Malfunction
    Date Received
    February 17, 2021
    Date of Event
    January 7, 2021
    Report Date
    March 22, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE HISTORY FILES WERE READ OUT AND ANALYZED. ACCORDING TO THE EQUIPMENT'S OPERATING HISTORY DATA, NO THERE WAS ANY DEVIATION IN VOLUME AND / OR FLOW, THE EQUIPMENT WORKED AS EXPECTED, THE COMPLAINT WAS THEREFORE CLASSIFIED AS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B.BRAUN (B)(4) AG INTERNAL REPORT (B)(4). THE AFFECTED DEVICE HAS BEEN REQUESTED TO SEND IT FOR INVESTIGATION TO BBM COMPLAINT PROCESSING. A FOLLOW-UP WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. NOTE: THIS REPORT IS BEING FILED FOR AN ITEM NUMBER THAT IS NOT SOLD IN THE UNITED STATES, HOWEVER SIMILAR ITEMS ARE SOLD IN THE UNITED STATES BY B. BRAUN MEDICAL, INC.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVER INFUSION / OPERATING UNIT". ACCORDING TO THE CUSTOMER: "SINCE (B)(6) 2021, HE STARTED WITH MORPHINE IN AN INFUSION PUMP AT 0.25 ML / H. ON (B)(6) 2021, AT 6:00 PM, AND INSTALLED THIS MORPHINE (SF45ML + 50MG MORPHINE) WITH RATE SETTING: 0.25ML / H. VTBI: 6ML, TIME: 24HS. AT 6:30 PM THE PATIENT IS REFERRED TO TOMOGRAPHY, AT 19:03HS THE EXAM ENDS AND SHE RETURNS TO THE ROOM AT 7:15 PM. AT 8 PM, PATIENT PATIENT, NURSE ENTERS THE ROOM TO EVALUATE IT AND REALIZE THAT THE BAG OF THE MORPHINE SOLUTION WAS EMPTY SINCE IT HAD BEEN INSTALLED AT 6 PM, IT CONFIRMS THE PUMP PROGRAM AND FINDS NO ERROR: RATE: 0.25ML / H, VTBI: 5.48 ML, TIME: 21HS 53MIN, INFUSED VOLUME: 0.53ML, TIME INFUSED: 2HS 7MIN. PATIENT WHO WAS RECEIVING A TOTAL OF MORPHINE OF 6MG IN 24 HOURS, RECEIVED 50 MG OF MORPHINE IN 2 HOURS. AFTER THE OCCURRED, THE PATIENT WAS AWAKE, CALM, THE INFUSION STOPPED, MEDICAL TEAM COMMUNICATION, CARRIED OUT NARCAN 1 AMPOULE, AND FOR SURVEILLANCE DUE TO OPIOID INTOXICATION IT WAS DECIDED TO TRANSFER IT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235939 INFUSOMAT PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1