BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18928462 · Received March 19, 2024

    Report

    Report Number
    2523676-2024-00285
    Event Type
    Malfunction
    Date Received
    March 19, 2024
    Date of Event
    February 23, 2024
    Report Date
    November 12, 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). THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    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.

    Description of Event or Problem · 0

    AS REPORTED BY THE USER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): PUMP DID NOT ALARM WHEN DRIP CHAMBER WAS EMPTY. NURSE NOTED AIR IN TUBING PRIOR TO AIR ALARM SOUNDING. IV TUBING WAS REMOVED FROM PUMP AND AIR WAS REMOVED MANUALLY WITH SYRINGE. 4ML OR AIR. IV TUBING WAS RETURNED TO PUMP AND THE FLUSH WAS ADMINISTERED TO COMPLETE INFUSION. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2553580 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061869283 04046964294570

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown