BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT® SPACE PUMP SETS WITH ULTRASITE®

    MDR report key: 5725561 · Received June 15, 2016

    Report

    Report Number
    9614279-2016-00036
    Event Type
    Malfunction
    Date Received
    June 15, 2016
    Date of Event
    May 3, 2016
    Report Date
    May 18, 2016
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC INC.
    Product Code
    FPA
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ACTUAL DEVICE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. HOWEVER, THE HOUSE RETAIN SAMPLES OF THE REPORTED LOT # 0061487508 WERE PULLED FOR EVALUATION. THE SETS WERE SUBJECTED TO LEAKAGE TESTING ACCORDING TO SPECIFICATION WITH ACCEPTABLE RESULTS. THERE WERE NO LEAKAGES OBSERVED ON THE RETAIN SAMPLES. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID REVEAL THAT DURING QUALITY CONTROL TESTING ONE UNIT LEAKED AT THE SONIC WELD AREA OF THE ULTRASITE Y VALVE. AFFECTED PRODUCT WAS CONTAINED AND RE-WORKED TO TEST FOR PRESSURE DECAY (LEAKAGE). WITHOUT THE ACTUAL SAMPLE, A THOROUGH SAMPLE ANALYSIS OF THE REPORTED EVENT COULD NOT BE PERFORMED AND THE EXACT LEAKAGE LOCATION COULD NOT BE DETERMINED. NO SPECIFIC CONCLUSIONS CAN BE DRAWN. HOWEVER, IN ORDER TO INVESTIGATE INCIDENTS RELATED TO ULTRASITE Y VALVES WHICH LEAK FROM THE SONIC WELD (LUER NUT-PISTON-BODY INTERFACE), B. BRAUN MEDICAL INC. OPENED A CORRECTIVE ACTION AND PREVENTIVE ACTION (CAPA) TO FURTHER INVESTIGATE ROOT CAUSE AND IDENTIFY ANY NECESSARY CORRECTIVE ACTION. BASED ON THE INITIAL CAPA INVESTIGATION, TOP POTENTIAL CAUSES HAVE BEEN IDENTIFIED AS WELDER OUTPUT VARIATIONS ON CERTAIN WELDER AND ULTRASONIC STACK COMBINATIONS OR HAVING AN UNSEATED LUER NUT IN COMBINATION WITH CERTAIN WELD PARAMETERS. THIS CAPA IS CURRENTLY IN IMPLEMENTATION PHASE TO EXECUTE THE CAPA ACTION PLAN, WHICH INCLUDES DEVELOPING AND TESTING METHODS FOR MEASURING AND CONTROLLING WELDER OUTPUT, AND REVISING THE WELD PROCESS TO ELIMINATE CONDITIONS THAT CAN CREATE AN UNSEATED LUER NUT. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: REPORTS THE SET LEAKED CHEMO MEDICATION (ADRIAMYCIN) AT THE LOWEST Y CONNECTOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379686 INFUSOMAT® SPACE PUMP SETS WITH ULTRASITE® SPACE PUMP IV ADMINISTRATION SET FPA B. BRAUN DOMINICAN REPUBLIC INC. 0061487508

    Patients

    Seq Age Sex Outcome Treatment
    1