BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 13175398 · Received January 6, 2022

    Report

    Report Number
    9610825-2021-00559
    Event Type
    Malfunction
    Date Received
    January 6, 2022
    Report Date
    February 28, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT (B)(4). THE COMPLAINT IS UNDER EVALUATION. A FOLLOW-UP REPORT WILL BE PROVIDED AFTER THE EXAMINATION RESULTS ARE AVAILABLE. 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 MEDICAL, INC. INTERNAL REPORT (B)(4). THE DEVICE WAS RETURNED FOR EVALUATION. DAMAGED DOOR HINGES WERE THE CAUSE OF THE REPORTED PROBLEM. BASED ON THE INFORMATION OF THE REPAIR/DAMAGE TYPE INCLUDED ON THE SERVICE REPORT, IT HAS BEEN CONCLUDED THAT THE REPORTED ISSUE IS THE RESULT OF USER MISHANDLING. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: AS REPORTED BY THE USER FACILITY: UNDERINFUSION - DID NOT PROVIDE MEDS WHILE IN USE MEDICATION INFUSING WAS ALTEPLASE NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31851 INFUSOMAT® PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male