BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV-FLASH TRANSFER SET

    MDR report key: 2213479 · Received August 16, 2011

    Report

    Report Number
    1423500-2011-10773
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 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). THIS INTERNATIONAL PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER, BUT IT IS BEING REPORTED AS IT IS THE SAME OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE U.S. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE A BATCH REVIEW CANNOT BE CONDUCTED. THE DEVICE HAS BEEN RECEIVED, BUT THE EVALUATION HAS NOT YET BEEN COMPLETED. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT COULD NOT BE CONFIRMED IN THE LAB. WE WERE UNABLE TO DUPLICATE THE COMPLAINT UNDER LAB CONDITIONS WITH THE RETURNED SAMPLE AND, THEREFORE, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED. THE RETURNED SAMPLE PASSED LEAK TEST AND DID NOT SHOW ANY TUBING CRACKS VISUALLY. IN THIS CASE THE EVALUATIONS DID NOT FIND ANY EVIDENCE OF ANY PROBLEM. RENAL QUALITY ENGINEERING WILL CONTINUE TO MONITOR THIS PRODUCT LINE FOR ADVERSE TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER (B)(4) THAT A LEAK WAS FOUND FROM A SCAR ON THE TUBING NEAR THE CONNECTION TO THE TITANIUM ADAPTER. THE SET HAD BEEN USED FOR 1 DAY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION. THERE WAS PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1