BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2090306 · Received May 16, 2011

    Report

    Report Number
    1423500-2011-06021
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 21, 2011
    Report Date
    April 21, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED SET WAS RECEIVED WITH NO CAP ON SPIKE (LOOSE IN POUCH) AND NO CAP ON PATIENT CONNECTOR AND PORT ASSEMBLY IN REFERENCE TO CONNECTION ISSUE. THE SET WAS FUNCTIONALLY HAND TIGHTENED TO A LAB TITANIUM ADAPTER WITHOUT DIFFICULTY AND PRESSURE TESTED UNDERWATER WITH NO LEAK NOTED. THE PORT WAS CONNECTED TO THE SPIKE AND NO ISSUES NOTED. DURING VISUAL INSPECTION NO ABNORMALITIES WERE NOTED. THE COMPLAINT COULD NEITHER BE CONFIRMED NOR DUPLICATED IN THE LAB. A ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED SHOULD ANY SIGNIFICANT SUPPLEMENTAL INFORMATION BECOME AVAILABLE

    Additional Manufacturer Narrative · 1

    (B)(4).A 510(K) NUMBER WAS NOT BE PROVIDED IN THE EMDR AS THIS PRODUCT IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE U.S. AND DOES NOT HAVE A 510(K) NUMBER. HOWEVER, IT WAS REPORTED BECAUSE IT IS THE SAME OR SIMILAR TO THE PRODUCT DISTRIBUTED WITHIN THE U.S.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER TO REPORT THAT THE SPIKE OF THE TRANSFER SET SEPARATED FROM THE PORT OF A UV TWIN BAG DURING DRAINING. THE CONNECTION WAS CAUGHT BY SOMETHING AND SEPARATED. THE SET HAD BEEN USED FOR 20 DAYS. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 TWIN BAG