BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE

    MDR report key: 14653854 · Received June 10, 2022

    Report

    Report Number
    9610825-2022-00225
    Event Type
    Malfunction
    Date Received
    June 10, 2022
    Date of Event
    March 24, 2022
    Report Date
    August 24, 2022
    Manufacturer
    B.BRAUN MELSUNGEN AG
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    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.

    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 SÃO GONÇALO, BRAZIL: TECHNICAL COMPLAINT WAS CONSIDERED UNCONFIRMED BECAUSE USERS DID NOT PROVIDE BASIC INFORMATION SUCH AS THE INFUSION PARAMETERS PROGRAMMED DURING THE ADVERSE EVENT AND/OR THE DATE ON WHICH THE ADVERSE EVENT OCCURRED.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY INFORMATION BY BBM SALES ORGANIZATION IN (B)(6): "UNDERINFUSION". "WHEN DID THE FAILURE OCCUR: DURING THERAPY REASON OF COMPLAINT: THE PUMP SIGNALED THAT IT HAD FINISHED THE DRUG, BUT THERE WAS STILL DRUG IN THE BAG."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678314 INFUSOMAT SPACE PUMP, INFUSION FRN B.BRAUN MELSUNGEN AG

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other