BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B.BRAUN

    MDR report key: 11651674 · Received April 12, 2021

    Report

    Report Number
    9610825-2021-00117
    Event Type
    Malfunction
    Date Received
    April 12, 2021
    Date of Event
    February 26, 2021
    Report Date
    April 12, 2021
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(6) AG INTERNAL REPORT (B)(4). REFERENCE SAMPLE: MODEL: SPACE COVER COMFORT. ARTICLE NO.: 8713145. SERIAL NO./LOT: 58603. PRODUCTION DATE: 2016-06-13. WARRANTY CLAIM: NO. RESULTS: A VISUAL TEST WAS PERFORMED ON THE SPACE COVER COMFORT. ALL COVER CAPS WERE PRESENT. THE HOUSING OF THE SPACE STATION WAS SOILED BY LIQUIDS. FOR A FUNCTION TEST THE SPACE COVER COMFORT WAS CONNECTED TO A SPACE STATION WITH INSERTED INFUSION PUMPS. THE SPACE COVER COMFORT FUNCTIONED ACCORDING TO SPECIFICATIONS. AFTER DISASSEMBLING THE SPACE COVER COMFORT, NO DAMAGES WERE FOUND INSIDE THE DEVICE. ASSESSMENT: THE COMPLAINT COULD NOT BE CONFIRMED. THE FIRE AT THE SPACE STATION DID NOT AFFECT OR DAMAGE THE SPACE COVER COMFORT. 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): FIRE AT SPACE STATION. SUDDENLY THERE WAS A FIRE AT THE DOCKING STATION OF THE SPACE INFUSION SYSTEM WITH CLEAR FLYING SPARKS. NOTE: EIGHT REPORTS ARE BEING FILED FOR ONE EVENT, BECAUSE ALL EIGHT DEVICES WERE INVOLVED IN THE ONE THERMAL EVENT AND THE CAUSE OF THE THERMAL EVENT COULD NOT BE TRACED TO ONE OF THE DEVICES. THIS REPORT IS BEING FILED FOR THE SPACESTATION COVER IN USE AT THE TIME OF THE EVENT. REPORT NUMBERS 9610825-2021-00110, 9610825-2021-00111, 9610825-2021-00112, 9610825-2021-00113, 9610825-2021-00114, 9610825-2021-00115, AND 9610825-2021-00116 ARE BEING FILED FOR THE OTHER DEVICES INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548738 B.BRAUN PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1