BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3931437 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22493
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATION IS ANTICIPATED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND DAMAGE WAS NOTED ON THE PATIENT ADAPTER. THE DAMAGE WAS DETERMINED TO BE UNRELATED TO THE REPORTED ISSUE. A LEAK TEST, CLEAR PASSAGE TEST, AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE UV SPIKE OUTSIDE DIAMETER WAS MEASURED AND WAS DETERMINED TO BE WITHIN SPECIFICATION. UPON CONCLUSION OF THE INVESTIGATION, THE REPORTED CONNECTION ISSUE COULD NOT BE IDENTIFIED AND A CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GAP WAS IDENTIFIED BETWEEN THE TRANSFER SET AND THE DISCONNECT CAP AFTER CONNECTION OF THE TWO DEVICES. THE CALLER STATED THE GAP OCCURRED WITH THE CHIP OF THE SPIKE PORT REMAINING ON THE SPIKE OF THE TRANSFER SET. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS INDICATED AS A RESULT OF THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409709 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 ENTERPRISE TSUNAGU SET CAP KIT