BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOMAT®

    MDR report key: 8793619 · Received July 16, 2019

    Report

    Report Number
    9614279-2019-00109
    Event Type
    Malfunction
    Date Received
    July 16, 2019
    Date of Event
    June 25, 2019
    Report Date
    November 27, 2019
    Manufacturer
    B. BRAUN DOMINICIAN REPULIC INC.
    Product Code
    FPA
    UDI-DI
    04046964294495
    PMA / PMN Number
    K142036
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 WAS RETURNED FOR EVALUATION. IN ADDITION, TWO (2) OPEN EQUASHIELDS IDENTIFYING LOTS 1820686 AND 1820647 AND SEVERAL VIDEOS WERE PROVIDED. VISUAL EXAMINATION OF ALL PROVIDED MATERIALS NOTED NO DEFECTS. THE RETURNED SET WAS FUNCTIONALLY TESTED PER SPECIFICATION AND THE REPORTED DEFECT OF UNRAVELLING WAS NOT ABLE TO BE REPLICATED. THEREFORE, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. IN ADDITION, EXTENSIVE ENGINEERING TEST REPORT (ETR) TESTING EXAMINED THE USE AND MISUSE OF UNRAVELING THROUGH MULTIPLE FACTORS INCLUDING EXCESS SILICONE, PRESENCE OF ALCOHOL VS NO ALCOHOL, AND VARIOUS DEGREES OF TORQUE TO TIGHTEN CONNECTION. THE REPORTED DEFECT WAS UNABLE TO REPLICATED. ALSO, ETR TESTING EXAMINED THE INTERACTION BETWEEN RETURNED ULTRASITE VALVES WITH EQUASHIELD ADAPTERS, ULTRASITE VALVES WITH UNOPENED EQUASHIELD ADAPTERS, THE PRESENCE OF WET VS DRY CONDITIONS, AND CLEANED VS UNCLEANED VALVES PER THE IFU. DURING TESTING, TWO INSTANCES OF UNRAVELING WERE OBSERVED. HOWEVER, NO DEFECTS WERE ABLE TO BE OBSERVED ON THE RETURNED ULTRASITE VALVES. A POSSIBLE DEFECT WAS NOTED ON THE UNOPENED EQUAHSIELD ADAPTER THREADS THAT COULD POSSIBLY CONTRIBUTE TO THE UNRAVELLING. THE EQUASHIELD ADAPTERS RETURNED WITH THE COMPLAINTS HAD FINE STRANDS OF PLASTIC NOTED ON THE THREADS. WHEN AN EQUASHIELD WITH THE POSSIBLE DEFECTS WAS CONNECTED AND DISCONNECTED WITH AN ULTRASITE VALVE, SIMILAR FINE STRANDS WERE OBSERVED. THE EQUASHIELD ADAPTERS HAVE BEEN SENT TO THE MANUFACTURER FOR FURTHER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE INVOLVED HAS NOT BEEN RECEIVED FOR EVALUATION AND THE INVESTIGATION IS ONGOING AT THIS TIME. A FOLLOW UP WILL BE SUBMITTED WHEN THE INVESTIGATION RESULTS BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT THE PRODUCT IS UNTWISTING AFTER CONNECTION AND CHEMO LEAKED. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    586989 INFUSOMAT® SET, ADMINISTRATION, INTRA FPA B. BRAUN DOMINICIAN REPULIC INC. 04046964294495

    Patients

    Seq Age Sex Outcome Treatment
    1