BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18161113 · Received November 17, 2023

    Report

    Report Number
    9610825-2023-00532
    Event Type
    Malfunction
    Date Received
    November 17, 2023
    Report Date
    April 26, 2024
    Manufacturer
    B BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN INTERNAL REPORT NUMBER (B)(4). 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 MEDICAL INTERNAL REPORT NUMBER (B)(4). THE COMPLAINT IS NOT CONFIRMED. A TWISTED LINE CAUSED THE OVERINFUSION AS SHOWN IN THE PROVIDED PHOTO FROM THE CUSTOMER. OVERINFUSION DUE TO MISHANDLING OF THE DISPOSABLE. 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 · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN PORTUGAL: "OVERINFUSION (4H INSTEAD OF 50H)". ACCORDING TO THE CUSTOMER: "HOSPITAL RECORDED AN EVENT WITH A DEVIATION ON THE INFUSION DURING THE ADMINISTRATION IN PATIENT. THE INFUSION WAS SCHEDULED FOR 50H, HOWEVER THE ENTIRE INFUSION OCCURRED IN 4 HOURS. CAUSE OF THE INCIDENT COULD BE RELATED TO THE TWISTING OF THE SILICONE SECTION OF THE ADMINISTRATION SYSTEM. DESPITE THE CHANGE IN THE FLOW RATE, REGARDING WHAT WAS PROGRAMMED, THE EQUIPMENT DID NOT TRIGGER ANY TYPE OF ALARM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    673981 INFUSOMAT® PUMP, INFUSION FRN B BRAUN MELSUNGEN AG 8713050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown