BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3062009 · Received April 16, 2013

    Report

    Report Number
    1416980-2013-09438
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    March 18, 2013
    Report Date
    March 25, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE SAMPLE WAS NOT AVAILABLE, AN EVALUATION COULD NOT BE PERFORMED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A FOLLOW UP MEDWATCH WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT. (B)(4).

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO'S TRANSFER SET BECAME DISCONNECTED FROM THEIR TITANIUM ADAPTOR. THE HP WAS HOSPITALIZED FOR PERITONITIS. THE CAUSE OF PERITONITIS WAS THE CONNECTION ISSUE AND SUBSEQUENT TOUCH CONTAMINATION WHEN THE HP PLACED THEIR HANDS OVER THE OPENING WHEN THE FLUID WAS COMING OUT. TREATMENT WAS NOT REPORTED. THE HP IS REPORTED TO BE RECOVERING. THIS IS REPORT 1 OF 2

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162587 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization DIANEAL, TITANIUM ADAPTOR, AND HOMECHOICE