BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19364298 · Received May 21, 2024

    Report

    Report Number
    2523676-2024-00519
    Event Type
    Malfunction
    Date Received
    May 21, 2024
    Date of Event
    April 19, 2024
    Report Date
    August 6, 2024
    Manufacturer
    B BRAUN MEDICAL INC
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). NO SAMPLE OR LOT WAS PROVIDED FOR EVALUATION. BASED ON THE DATA FROM THE INVESTIGATION WE ARE UNABLE TO DETERMINE THE ROOT CAUSE OF THE REPORTED INCIDENT. THE REPORTED DEFECT WAS UNABLE TO BE CONFIRMED. WE WILL MAINTAIN THIS REPORT FOR FURTHER REFERENCES AND CONTINUE TO MONITOR OTHER REPORTS FOR SIMILAR OCCURRENCES. IF ANY ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INTERNAL REPORT NUMBER (B)(4). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 0

    ACCORDING TO THE EVENT DESCRIPTION: PER INFORMATION PROVIDED FROM THE UNIVERSITY OF MARYLAND / B. BRAUN ON-SITE WORKSHOP, HELD ON (B)(6) 2024, THIS PUMP WAS REPORTED DURING ROUNDING TO BE ATTACHED TO AN INCIDENT DEEMED TO REQUIRE REPORTING AND INVESTIGATION. THE DEVICE WAS NOTED TO BE INVOLVED IN THE FOLLOWING EVENT: PUMP SUDDENLY STOPPED MID-INFUSION, NO ALARMS, NO CLEAR REASON. THIS CASE IS FOR THE IV LINES USED WITH INFUSOMAT SPACE PUMP WITH SERIAL NUMBER 921488 AND CUSTOMER FACILITY ASSET # 1-59542. THE PUMP PASSED TSC ON (B)(6) 2024, BUT WAS TESTED FOR "AIR IN LINE" REPORTED. 921488, AIR IN LINE, TSC, Y, (B)(6) 2024 NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1220632 INFUSOMAT® SET, ADMINISTRATION, INTRAVASULAR FPA B BRAUN MEDICAL INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown