BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 2904097 · Received January 9, 2013

    Report

    Report Number
    1416980-2013-00620
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    December 16, 2012
    Report Date
    December 17, 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 IS A PRODUCT NOT DISTRIBUTED IN THE US AND DOES NOT HAVE A 510K NUMBER. THE SAMPLE HAS BEEN REPORTED TO BE AVAILABLE FOR EVALUATION AND HAS BEEN REQUESTED. SHOULD THE SAMPLE BE RETURNED OR ADDITIONAL INFORMATION RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A CONNECTION ISSUE WAS NOT CONFIRMED AND THE ROOT CAUSE COULD NOT BE DETERMINED. A SAMPLE EVALUATION WAS PERFORMED. A VISUAL INSPECTION WAS PERFORMED WITH NO ISSUES NOTED. A LEAK TEST, A CLEAR PASSAGE TEST, AND A CLAMP FUNCTION TEST WERE ALL PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS MEASURED AND WAS WITHIN SPECIFICATION LIMITS. A BATCH REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Description of Event or Problem · 1

    A DOCTOR CONTACTED BAXTER (B)(4) REGARDING A CONNECTION ISSUE WITH A UV FLASH TRANSFER SET. THE DOCTOR RELAYED A REPORT FROM THE HOME PATIENT (HP) WHO STATED THAT THE DISCONNECT KIT CAME OFF FROM THE SPIKE OF THE TRANSFER SET DURING USE. THERE WAS PATIENT INVOLVEMENT. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10904 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 DISCONNECT KIT