BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFUSOR SPACE

    MDR report key: 16075690 · Received December 29, 2022

    Report

    Report Number
    9610825-2022-00562
    Event Type
    Malfunction
    Date Received
    December 29, 2022
    Date of Event
    July 13, 2022
    Report Date
    August 22, 2023
    Manufacturer
    B. BRAUN MELSUNGEN AG
    Product Code
    FRN
    PMA / PMN Number
    K062699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MELSUNGEN AG 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 400579617. THE ATTACHED HISTORY FILES WERE ANALYSED. BASED ON THE HISTORY FILES THE ERROR CODE "FLOW-ALARM" COULD BE FOUND DIRECTLY AFTER STARTING THE INFUSION. NO OTHER ABNORMALITIES WERE FOUND IN THE HISTORY FILES. THE COMPLAINT COULD NOT BE CONFIRMED. 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 (TRANSLATION OF USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN IRELAND: "FREE FLOW." CUSTOMER INFORMATION: "FLOW ALARM. REPORTED AS FAULTY. CARE AREA: CONNOLLY. ISSUE OCCURRED: (B)(6) 2022."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    524058 PERFUSOR SPACE SYRINGE PUMP FRN B. BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown