BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3241313 · Received July 22, 2013

    Report

    Report Number
    1416980-2013-19336
    Event Type
    Malfunction
    Date Received
    July 22, 2013
    Date of Event
    June 27, 2013
    Report Date
    June 27, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF BAXTER'S INVESTIGATION, OR IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER WAS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. HOWEVER, NOT CLOSING THE TRANSFER SET WHEN DISCONNECTING IS A KNOWN CAUSE OF A LEAK. PROPER USER INSTRUCTIONS ARE ADDRESSED IN ?THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE? WHICH IS SHIPPED WITH EVERY HOMECHOICE DEVICE. THE GUIDE PROVIDES INSTRUCTIONS FOR PROPERLY DISCONNECTING AND INSTRUCTS THE USER TO ?CLOSE THE CLAMP ON THE PATIENT LINE AND CLOSE YOUR TRANSFER SET." A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    DURING TROUBLESHOOTING FOR THE UNRELATED ALARMS, IT WAS REPORTED THAT BEFORE REACHING DRAIN 4 OF 5 OF THE THERAPY, THE HP HAD DISCONNECTED FROM THE HOMECHOICE (HC) AND, AS A RESULT, LOST SOME SOLUTION DUE TO NOT CLOSING THE TRANSFER SET. AFTER CLEARING THE UNRELATED ALARMS, THE HP WAS ABLE TO SAFELY BYPASS TO FILL 5 OF 5. THERE WAS NO REPORT OF PATIENT INJURY, MEDICAL INTERVENTION, 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
    341666 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 HOMECHOICE