BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    B. BRAUN

    MDR report key: 11651673 · Received April 12, 2021

    Report

    Report Number
    9610825-2021-00116
    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

    (B)(4). REFERENCE SAMPLE: MODEL: SPACESTATION WITH SPACECOM. ARTICLE NO.: 8713142. SERIAL NO./LOT: (B)(4). PRODUCTION DATE: 2007-09-05. WARRANTY CLAIM: NO. RESULTS: A VISUAL TEST WAS PERFORMED ON THE SPACE STATION. TWO TUBE GUIDES WERE MISSING. ALL COVER CAPS OF THE REAR PANEL WERE PRESENT. THE HOUSING OF THE SPACE STATION WAS SOILED BY LIQUIDS. THE PINS OF THE CONNECTORS F2A-F2D WERE OXIDIZED BY RESIDUALS OF LIQUID. THE AREA AROUND THE MAINS VOLTAGE CONNECTOR WAS BURNT AND SOOT WAS PRESENT ON THE MAINS POWER SUPPLY HOLDER, MAINS CABLE AND THE REAR- AS WELL AS THE FRONT-HOUSING. THE MAINS CABLE ALSO WAS DAMAGED AND THE PLASTIC PARTS OF THE PLUG WERE DEFORMED BY HEAT. DUE TO THE DAMAGE, A FUNCTIONAL TEST OF THE MAINBOARD AND POWER SUPPLY WAS NOT PERFORMED FOR SAFETY REASONS. THE LOCKING MECHANISMS OF THE MODULE LOCK WERE FUNCTIONING. AFTER DISASSEMBLING THE REAR PANEL, WE DETECTED THAT THERE WAS LIQUID AND SOOT PARTICLES INSIDE THE DEVICE. EXCEPT LIQUID AND SOOT, NO FURTHER DAMAGES WERE DETECTED. THE COM-BOARD WAS ASSEMBLED INTO A TESTING STATION AND PERFORMED WELL. A LAN CONNECTION COULD BE ESTABLISHED. THE DELIVERED MAINS CABLE WAS NOT A CABLE OF THE AFFECTED BATCH OF THE COMPANY (B)(4) FROM 2016 TO 2018. ASSESMENT: THE COMPLAINT COULD NOT BE CONFIRMED. THE FAULT COULD BE TRACED BACK TO A LIQUID DAMAGE. THE LIQUID FLEW INTO THE MAINS CONNECTOR AND CAUSED THE HEAT BUILD-UP. THE FLYING SPARKS WERE PROBABLY CAUSED BY A MIXTURE OF THE LIQUIDS AND PARTS OF THE MAINS CABLE. IN CONSULTATION WITH THE DEVELOPMENT, A FAULTY MAINS CABLE COULD BE EXCLUDED. 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 ONE OF THE SPACESTATIONS THAT WAS 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 9610825-2021-00117 ARE BEING FILED FOR THE OTHER DEVICES INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    548392 B. BRAUN PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1