BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 19115702 · Received April 16, 2024

    Report

    Report Number
    2523676-2024-00343
    Event Type
    Malfunction
    Date Received
    April 16, 2024
    Date of Event
    March 24, 2024
    Report Date
    November 15, 2024
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964294570
    PMA / PMN Number
    K142036
    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 INTERNAL REPORT NUMBER (B)(4). NO SAMPLE WAS PROVIDED FOR EVALUATION. DUE TO COMPLAINTS OF THIS NATURE, CORRECTIVE ACTIONS WERE PERFORMED TO REVISE SPECIFICATIONS WHICH LIMIT UNIT-TO-UNIT VARIATION IN TUBING OUTER DIAMETERS AND INCREASED THE LENGTH OF THE TUBING THAT CONTACTS THE AIR SENSOR. THE REDUCED VARIATION IN TUBING OUTER DIAMETER AND LENGTH REVISION IMPROVES THE COUPLING BETWEEN THE ADMINISTRATION SET AND THE AIR-IN-LINE SENSOR REDUCING THE POTENTIAL FOR FALSE AIR-IN-LINE ALARMS. B. BRAUN MEDICAL INC. HAS INITIATED A VOLUNTARY MEDICAL DEVICE CORRECTION 2523676-9/26/23-004-C FOR MULTIPLE BATCHES OF INFUSOMAT® PUMP SETS MANUFACTURED BETWEEN 01.JAN.2022 AND 17.AUG.2023. 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

    AS REPORTED BY THE USER FACILITY: DETAILS OF PROBLEM AND ACTIONS TAKEN TO DATE: FREQUENT ALARMING FOR AIR IN THE LINE - TOOK OUT OF PUMP, WIPED DOWN SENSORS, TRIED TO TAP AIR BUBBLES OUT. LET IT RUN BY GRAVITY FOR A BIT THEN PUT BACK IN THE PUMP AND WASN'T AN ISSUE AGAIN. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1445946 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061875291 04046964294570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown