BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT SPACE PUMP SET WITH ULTRASITE

    MDR report key: 4809346 · Received May 29, 2015

    Report

    Report Number
    9614279-2015-00029
    Event Type
    Malfunction
    Date Received
    May 29, 2015
    Report Date
    May 11, 2015
    Manufacturer
    B. BRAUN DOMINICAN REPUBLIC
    Product Code
    FRN
    PMA / PMN Number
    K062700
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. (B)(4). ONE USED SPACE PUMP IV SET, WITHOUT PACKAGING, WAS RECEIVED FOR EVALUATION. THE SET WAS SUBJECTED TO AN AIR PRESSURE (LEAKAGE) TEST ACCORDING TO SPECIFICATION. LEAKAGE WAS OBSERVED AT THE SONIC WELD SEAL OF THE PROXIMAL ULTRASITE Y-VALVE. REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBERS DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR INVOLVED ULTRASITE Y-VALVE. THERE WERE NO OTHER REPORTS OF THIS NATURE AGAINST THE REPORTED LOT NUMBERS. THE INVESTIGATION INTO THIS REPORTED EVENT IS ONGOING. FOLLOWING THE RECEIPT OF ADDITIONAL INFORMATION AND/OR COMPLETION OF THE INVESTIGATION A FOLLOW-UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    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 TUBING AND IT STARTED LEAKING AT THE Y-SITE WHERE THE PIGGYBACK IS SCREWED IN. POSSIBLE LOT NUMBER REPORTED: LOT # 0061420699 - MFG: 03/2015 - EXPIRATION: 02/28/2020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    350610 INFUSOMAT SPACE PUMP SET WITH ULTRASITE INFUSOMAT SPACE PUMP IV ADMIN SET FRN B. BRAUN DOMINICAN REPUBLIC NA 0061405405

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN