BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 18084790 · Received November 7, 2023

    Report

    Report Number
    2523676-2023-00700
    Event Type
    Malfunction
    Date Received
    November 7, 2023
    Date of Event
    October 18, 2023
    Report Date
    December 29, 2023
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    FPA
    UDI-DI
    04046964186165
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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) PHOTOGRAPH AND ONE (1) USED SAMPLE WITH AN OPEN PACKAGE RETURNED FOR EVALUATION. THE SAMPLE AND PHOTOGRAPH WERE VISUALLY EVALUATED, AND A DETACHMENT WAS OBSERVED AT THE BONDED JOINT OF THE TUBING AND THE PROXIMAL SIDE OF THE PUMP SEGMENT. NO STRESS MARKS RIPS, OR TEARS WERE PRESENT, AND THERE WERE NO SIGNS OF SOLVENT. BASED ON THE RESULTS OF THE SAMPLE EVALUATION, THE REPORTED DEFECT IS CONFIRMED. A REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM (DSMS) DATABASE WAS PERFORMED FOR THE REPORTED LOT NUMBER AND NO ABNORMALITIES OR NON-CONFORMANCES WERE NOTED DURING THE IN PROCESS OR FINAL PRODUCT INSPECTION. ALTHOUGH THE DEFECT WAS CONFIRMED THE EXACT ROOT CAUSE WAS NOT ABLE TO BE DETERMINED AT THIS TIME.AN APPROVED PROJECT IS IN PLACE TO FURTHER ADDRESS ISSUES WITH DISCONNECTION AT THE BONDED JOIN.

    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: DEFECTIVE INFUSOMAT BLOOD SET. DETAILED INQUIRY DESCRIPTION: THE OMC INFUSION CENTER HAD YET ANOTHER PRIMARY TUBING JUST FALL APART PRIOR TO GOING ONTO THE PUMP. THE INFUSION TEAM IS FRUSTRATED AS WE HAVE NUMEROUS ISSUES IN THE PAST FEW WEEKS WITH TUBING FALLING APART AND LEAKS. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340828 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN MEDICAL INC. 0061894400 04046964186165

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown