BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 16060188 · Received December 28, 2022

    Report

    Report Number
    9610825-2022-00554
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    February 8, 2021
    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. THE PUMP SWITCHED ON AND A SPACE LINE NEUTRAPUR WAS INSERTED. THE INFUSION WAS STARTED WITH A RATE OF 359,40ML/H AND A VTBI OF 689ML. DURING THE INFUSION ONE "FLOW-ALARM" AND ONE "TOO FEW DROPS" ALARM OCCURRED. THE REASON FOR THE ALARM COULD NOT BE CLARIFIED. AT THE END OF THE INFUSION 689ML HAS BEEN INFUSED. NO OTHER ABNORMALITIES WERE FOUND. 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: "ISSUE OCCURRED: (B)(6) 2021 IN HODU. CUSTOMER DETERMINED IT WAS USER ERROR. 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
    1922877 INFUSOMAT SPACE PUMP, INFUSION, PRODUCT CODE: FRN FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown