BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4103233 · Received September 19, 2014

    Report

    Report Number
    1416980-2014-32423
    Event Type
    Malfunction
    Date Received
    September 19, 2014
    Date of Event
    August 26, 2014
    Report Date
    August 26, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION, THEREFORE, THE REPORTED CONDITION COULD NOT BE VERIFIED AND THE CAUSE COULD NOT BE IDENTIFIED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CONNECTION BETWEEN THE TITANIUM ADAPTER AND TRANSFER SET WAS NOT TIGHT ENOUGH. THIS OCCURRED DURING DWELL TWO OF FIVE ON THE HOMECHOICE. THE PATIENT WAS CONNECTED AT THE TIME OF THE EVENT. DURING TROUBLESHOOTING, THE PATIENT¿S NURSE STATED THAT THE CONNECTION BETWEEN THE TRANSFER SET AND THE CATHETER WAS NOT TIGHT ENOUGH AND A LEAK OCCURRED. THE NURSE FURTHER STATED THAT THEY WERE ABLE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582525 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR HOMECHOICE| CATHETER