BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3933010 · Received July 14, 2014

    Report

    Report Number
    1416980-2014-22580
    Event Type
    Malfunction
    Date Received
    July 14, 2014
    Date of Event
    May 7, 2014
    Report Date
    June 19, 2014
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE TITANIUM ADAPTER WAS NOT RETURNED, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A TITANIUM ADAPTER DISCONNECTED FROM A TRANSFER SET. AFTER THE DISCONNECTION THE HOME PATIENT (HP) RECONNECTED THE TRANSFER SET TO THE TITANIUM ADAPTER. THE HP WAS BEING TREATED FOR PERITONITIS AT THE TIME OF THE EVENT, BUT THERE WAS NO ADDITIONAL PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    410757 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG