BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 16060187 · Received December 28, 2022

    Report

    Report Number
    9610825-2022-00553
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 11, 2020
    Report Date
    August 23, 2023
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    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). THE DEVICE WAS NOT AVAILABLE. ONLY THE HISTORY DATA WAS SENT FOR INVESTIGATION. RESULTS: THE DEVICE HISTORY FILES WERE ANALYSED. A NEW THERAPY WAS SELECTED AND A VOLUME OF 149ML WITH A RATE OF 298ML/H WAS SELECTED. THE INFUSION STARTED AND 27 MINUTES LATER AN UPSTREAM ALARM OCCURRED. THE INFUSION WAS CONTINUED AND 4 MINUTES LATER THE VOLUME HAS DONE. AT THIS TIME, 149ML HAS BEEN INFUSED. THE REASON FOR THE UPSTREAM ALARM COULD NOT BE CLARIFIED. NO OTHER ABNORMALITIES WERE FOUND. 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 · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "UNDERINFUSION." CUSTOMER STATEMENT: "QUERY ON INFUSION. CHEMO INFUSION DID NOT INFUSE. PUMP SET UP TO INFUSE 149ML OVER 30MIN. WHEN THE NURSE RETURNED TO THE PUMP THE VOLUME DID NOT INFUSE. ISSUE OCCURRED: (B)(6) 2020. PHONE CALL FROM B. BRAUN DIGITAL HEALTH & HEALTHCARE TECHNOLOGY LEAD TO SAY HE WAS IN (B)(6) WITH THE CLINICAL ENGINEER FROM (B)(6) WHO HAD A LIST OF ISSUES WITH INFUSOMAT SPACE PUMPS BUT THE VOLUME OF COMPLAINTS ON HIS LIST DID NOT SEEM TO CORRESPOND WITH THE VOLUME OF COMPLAINTS FROM OUR (B. BRAUN) RECORDS. THE CLINICAL ENGINEER FROM (B)(6)FORWARDED HIS LIST ON FOR REVIEW. AFTER REVIEW IT WAS NOTICED THAT THERE WERE SOME ISSUES IN RELATION TO PUMP SERIAL NUMBERS THAT WERE NOT REPORTED TO B. BRAUN / RECORDED ON OUR DATABASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1922876 INFUSOMAT SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown