BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 4487858 · Received February 5, 2015

    Report

    Report Number
    1416980-2015-04397
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    November 12, 2014
    Report Date
    November 13, 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 FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED VIA THE NAKED EYE AND MICROSCOPE, A DAMAGED PORT WAS NOTED. A LEAK TEST WAS PERFORMED WITH A LEAK NOTED FROM THE DAMAGED PORT. A CLEAR PASSAGE TEST AND CLAMP FUNCTION TEST WERE PERFORMED WITH NO ISSUES NOTED. THE SAMPLE WAS CONNECTED TO A UC SET USING A UV FLASH MACHINE WITH NO ISSUES NOTED. THE REPORTED CONDITION WAS IDENTIFIED DURING EVALUATION BUT THE CAUSE COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SPIKE PORT OF THE DISCONNECT Y-SET WAS BENT DURING USE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84428 CAPD DISCONNECT Y SET SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1