BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 20945039 · Received December 16, 2024

    Report

    Report Number
    2523676-2024-01109
    Event Type
    Malfunction
    Date Received
    December 16, 2024
    Date of Event
    October 30, 2024
    Report Date
    January 23, 2025
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    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). ONE (1) USED SAMPLE WITHOUT PACKAGING AND ONE (1) PHOTOGRAPH OF THE IV SET WERE PROVIDED FOR EVALUATION. THE SAMPLE ARRIVED WITH AN EQUA SHIELD ATTACHED TO THE SPIN LOCK CONNECTOR. THE EQUA SHIELD COULD NOT BE DETACHED FROM THE SPIN LOCK, WHICH PREVENTED THE SET FROM BEING GRAVITY PRIMED TO VERIFY THE REPORTED DEFECT. HOWEVER, THE PRESENCE OF AIR BUBBLES WERE OBSERVED. THE REPORTED DEFECT WAS CONFIRMED. 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: BRIEF INQUIRY DESCRIPTION: AIR IN LINE ALARMS. ETOPOSIDE DELAYED DUE TO AIR IN LINE ALARMS. SCHEDULED AT 1230, DUE TO "BUBBLES" IN THE IV TUBING, UNABLE TO INFUSE CHEMOTHERAPY IN A TIMELY MANNER. ATTEMPTED TO USE 2 DIFFERENT B. BRAUN PUMPS, TROUBLE SHOOT ATTEMPTS MADE BY BEDSIDE RN, CHARGE RN, H11A SUPER USER RN, AND H11A CLINICAL LEADER AND H12 RN MANAGER. THIS PROCESS TOOK 55 MINUTES TO GET CHEMO STARTED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2390979 INFUSOMAT® SET, ADMINISTRATION, INTRAVASCULAR FPA B. BRAUN MEDICAL INC. 0061827353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female