BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2880459 · Received December 19, 2012

    Report

    Report Number
    1416980-2012-07766
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 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). THE SAMPLE WAS EVALUATED BY BAXTER. A VISUAL INSPECTION WAS PERFORMED WITH A FLASH ON THE PATIENT ADAPTER NOTED. LEAK TESTING WAS PERFORMED WITH A LEAK AT THE PATIENT ADAPTER CONNECTION TO THE TITANIUM NOTED, WITH A LEAK RATE MEASURING LESS THAN ONE ML. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE SAMPLE WAS CONFIRMED FOR THE REPORTED PROBLEM; HOWEVER, THE ROOT CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE DEVICE HAS BEEN RECEIVED AT BAXTER FOR EVALUATION. HOWEVER, THE EVALUATION IS NOT COMPLETE AT THIS TIME. A FOLLOW-UP REPORT WILL BE FILED UPON COMPLETION OF THE DEVICE EVALUATION, OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Description of Event or Problem · 1

    A DOCTOR CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A UV FLASH TRANSFER SET. THE DOCTOR STATED THAT THE PATIENT CONNECTOR OF THE SET WAS NOT WELL CONNECTED WITH THE TITANIUM ADAPTOR WHEN THE CUSTOMER CHANGED THE TRANSFER SET. THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED.

    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 ADAPTOR