BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPACE®STATION

    MDR report key: 23095306 · Received September 19, 2025

    Report

    Report Number
    9610825-2025-00536
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 21, 2025
    Report Date
    November 5, 2025
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). VISUAL INSPECTION: UPON ANALYSIS OF THE RECEIVED PICTURES, IT WAS OBSERVED THAT THE DEVICE HOUSING IN THE AREA SURROUNDING THE MAINS VOLTAGE CONNECTOR WAS BURNED, ALONG WITH THE MAINS CABLE ITSELF. CONCLUSION: THE DEFECT COULD BE CONFIRMED. THE DESCRIBED ERROR PATTERN COULD BE COMPREHENDED IN THE PICTURES. THE ERROR PATTERN COULD BE RETRACED TO A LIQUID DAMAGE. NOTE: THIS REPORTED 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW- UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE. NOTE: THIS REPORTED 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. PLEASE NOTE, THIS DEVICE IS DISTRIBUTED OUTSIDE THE US AND NO GUDID INFORMATION EXISTS. IT IS BEING REPORTED DUE TO A SIMILAR DEVICE BEING MARKETED WITHIN THE US WITH THE FOLLOWING INFO: UDI NUMBER (B)(4).

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: ""DURING THE INFUSION OF A THERAPY, THE STATION WAS NOT CHARGING THE PUMP'S BATTERY, AND THE CONTROL PANEL OF THE PATIENT BOX TO WHICH THE STATION WAS CONNECTED INDICATED AN ANOMALY OF SOME DEVICE. THE NURSE PROCEEDED TO CHECK ALL CONNECTED DEVICES, AND AT THE MOMENT OF CHECKING THE STATION'S POWER SUPPLY, A FIRE OCCURRED AT THE ENTRY PORT OF THE POWER SUPPLY CABLE, WITH THE DEVELOPMENT OF SMOKE AND FLAMES."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1766985 SPACE®STATION PUMP, INFUSION FRN B BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown