BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UV FLASH TRANSFER SETS

    MDR report key: 3083428 · Received April 29, 2013

    Report

    Report Number
    1416980-2013-10719
    Event Type
    Malfunction
    Date Received
    April 29, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 5, 2013
    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 HAS BEEN RECEIVED BY BAXTER, AND 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). THE DEVICE WAS RECEIVED FOR EVALUATION. VISUAL INSPECTION FOUND A BENT SPIKE AND TUBING THAT WAS CUT OFF NEXT TO THE SLEEVE THAT WAS CUT BY THE CUSTOMER TO SEND THE DEVICE IN. LEAK TESTING WAS PERFORMED WITH NO ISSUES NOTED FOR SLEEVE TO SPIKE ASSEMBLY; CLEAR PASSAGE TESTING AND CLAMP FUNCTION TESTING WERE PERFORMED WITH NO ISSUES NOTED. THE OUTSIDE DIAMETER OF THE UV SPIKE WAS FOUND TO BE WITHIN SPECIFICATIONS. THE REPORTED PROBLEM WAS NOT CONFIRMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THAT IT WAS DIFFICULT TO DISCONNECT THE SPIKE OF A TRANSFER SET FROM A PORT OF A TWIN BAG WHEN THE PATIENT USES CLEAN FLASH. 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
    183692 UV FLASH TRANSFER SETS SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1