BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 3161740 · Received June 11, 2013

    Report

    Report Number
    1416980-2013-14924
    Event Type
    Malfunction
    Date Received
    June 11, 2013
    Date of Event
    May 24, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS UNAVAILABLE FOR FURTHER INVESTIGATION. SHOULD RELEVANT ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A LEAK THAT OCCURRED DURING A PATIENT'S INITIAL DRAIN FOR PERITONEAL DIALYSIS THERAPY. SOLUTION WAS NOTED TO BE COMING OUT OF THE DOOR OF THE HOMECHOICE MACHINE. THE CAUSE OF THE LEAK WAS UNKNOWN. THE PATIENT REPLACED THE CURRENT SET UP WITH NEW SUPPLIES BUT WAS UNABLE TO RESUME THERAPY SUCCESSFULLY. THE PATIENT WAS ADVISED THAT A SWAP OF THE MACHINE WAS REQUIRED AND IT WAS RECOMMENDED THAT THEY CONTACT THEIR REGISTERED NURSE (RN). THERE WAS PATIENT INVOLVEMENT, BUT THERE WAS NO REPORT OF PATIENT INJURY OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262571 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE