BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 14337009 · Received May 9, 2022

    Report

    Report Number
    9610825-2022-00158
    Event Type
    Malfunction
    Date Received
    May 9, 2022
    Report Date
    August 18, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN (B)(4) 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 HAS BEEN INVESTIGATED IN OUR SERVICE DEPARTMENT AT B. BRAUN MELSUNGEN AG, MELSUNGEN, GERMANY: THE DEVICE WENT THROUGH THE REPAIR PROCESS BECAUSE IT WAS NOT MARKED AS A COMPLAINT. DURING THE REPAIR, THE P2 CONNECTOR AND THE LOCK BOLT DRIVE WAS REPLACED. NO OTHER DAMAGES WERE FOUND DURING THE FUNCTIONAL TEST. THE DEVICE WAS CALIBRATED AND CHECKED. NO MALFUNCTION WAS FOUND DURING THIS PROCESS. THE COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WENT THROUGH THE REPAIR PROCESS BECAUSE IT WAS NOT MARKED AS A COMPLAINT.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "OVERINFUSION". ACCORDING TO THE CUSTOMER: "PASSAGE IN 15H INSTEAD OF 16H.W.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1840328 INFUSOMAT SPACE PUMP, INFUSION, FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown