BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2822119 · Received November 7, 2012

    Report

    Report Number
    1416980-2012-04247
    Event Type
    Malfunction
    Date Received
    November 7, 2012
    Date of Event
    October 19, 2012
    Report Date
    October 23, 2012
    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 COMPLAINT FOR A CONNECTION ISSUE WAS CONFIRMED; HOWEVER, NO ROOT CAUSE COULD BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED. A CLEAR PASSAGE TEST WAS PERFORMED WITH NO ISSUES NOTED. A CLAMP FUNCTION TEST WAS PERFORMED WITH NO ISSUES NOTED. FUNCTIONALLY, THE SET WAS HAND TIGHTENED WITH A LAB TITANIUM ADAPTER WITH DIFFICULTY NOTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD THE DEVICE BE RECEIVED BY BAXTER FOR EVALUATION, A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF AN EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    A DOCTOR REPORTED TO BAXTER A CONNECTION ISSUE RELATED TO THE TRANSFER SET. THE DOCTOR REPORTED THAT THE PATIENT CONNECTOR WAS NOT CONNECTED WITH THE TITANIUM ADAPTER WELL WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THE CUSTOMER REPORTED THAT THERE WAS A GAP (2-3MM) BETWEEN EACH CONNECTOR. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE WAS PATIENT INVOLVEMENT.

    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 H12F11067

    Patients

    Seq Age Sex Outcome Treatment
    1 TITANIUM ADAPTER