BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3771205 · Received April 24, 2014

    Report

    Report Number
    1416980-2014-13240
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 23, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE TRANSFER SET WAS DISCARDED AND THE LOT NUMBER WAS UNKNOWN, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, A REGISTERED NURSE (RN) INDICATED THAT THE HP WAS USING A PLASTIC CATHETER ADAPTER WITH THE TRANSFER SET. THE TRANSFER SET LABELING EXPLAINS THAT THE SET IS TO BE USED WITH A BAXTER TITANIUM ADAPTOR. FURTHERMORE, IT WARNS, ¿BAXTER HAS NO CONTROL OVER VARIABILITY, TOLERANCES, MECHANICAL STRENGTH OR CHANGES IN THESE PRODUCTS WHICH MAY BE MADE FROM TIME TO TIME. THEREFORE, BAXTER CANNOT ENSURE THAT THE DIALYSIS PRODUCTS OF OTHER MANUFACTURERS, WHEN CONNECTED WITH ITS PRODUCTS, WILL FUNCTION IN A SATISFACTORY MANNER.¿ A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A HOME PATIENT¿S (HP) TRANSFER SET DISCONNECTED FROM THEIR CATHETER DURING THE INITIAL DRAIN OF AUTOMATED PERITONEAL DIALYSIS (APD) THERAPY. FOLLOW UP WITH A REGISTERED NURSE (RN) REVEALED THAT THE CATHETER ADAPTER WAS PLASTIC. THE HP WAS HOSPITALIZED AND TREATED WITH AN UNKNOWN ANTIBIOTIC (DOSE AND FREQUENCY UNKNOWN) AS A PRECAUTION, BUT THERE WAS NO PATIENT INJURY INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250073 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR HOMECHOICE