BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 17480045 · Received August 8, 2023

    Report

    Report Number
    9610825-2023-00381
    Event Type
    Malfunction
    Date Received
    August 8, 2023
    Date of Event
    July 5, 2023
    Report Date
    November 6, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT 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.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG INTERNAL REPORT (B)(4). AS NO SAMPLE AND NO MEANINGFUL PICTURE WAS PROVIDED, PROPER INVESTIGATION ON MALFUNCTION COULD NOT BE PERFORMED. HENCE, THE COMPLAINT IS CONSIDERED AS NOT CONFIRMED. 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 · 0

    AS REPORTED BY THE USER FACILITY INFORMATION IN UNITED KINGDOM: "OVER INFUSION." ACCORDING TO THE CUSTOMER: "DATE: (B)(6) 2023 TIME: 11:30 DETAILS: PATIENT ATTENDED MEDICAL DAY UNIT FOR IV FUROSOMIDE INFUSION WHICH WAS COMMENCED AS PRESCRIBED. WITHIN 10 MINUTES OF THIS BEING SET UP THE MACHINE STARTED BEEPING TO INFORM STAFF THAT SYRINGE WAS NEARLY EMPTY DESPITE BEING SET FOR 3 HOURS MACHINE WAS SET AT AND WAS SHOWING THE FOLLOWING ON THE DISPLAY SCREEN: VTBI- 43.79MLS RATE- 14.67MLS/HR TIME- 3:00HRS IMMEDIATE ACTION: INFUSION STOPPED IMMEDIATELY INCIDENT EXPLAINED TO THE PATIENT AND APOLOGIES GIVEN CARDIOLOGY SPECIALIST NURSE CONTACTED AND INFORMED OBSERVATIONS CHECKED REPEAT BLOODS TAKEN FOR U&E'S- RENAL FUNCTION OFF PRIOR TO INFUSION. HAS HAD U&E'S TAKEN BEFORE INFUSION STARTED. REVIEWED ON UNIT BY CARDIOLOGY SPECIALIST NURSE SEVERITY: 2. MINOR LIKELIHOOD: 2. UNLIKELY RISK RATING: LOW (YELLOW)".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481851 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown