BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4240313 · Received November 10, 2014

    Report

    Report Number
    1416980-2014-39675
    Event Type
    Malfunction
    Date Received
    November 10, 2014
    Date of Event
    September 23, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED EVENT WAS DETERMINED TO BE DUE TO THE PATIENT NOT CLOSING THE TRANSFER SET ALL THE WAY AT THE TWIST CLAMP CAUSING THE LEAK. THE HOMECHOICE AND HOMECHOICE PRO APD SYSTEMS PATIENT AT-HOME GUIDE INSTRUCTS THE USER THAT THE TRANSFER SET SHOULD BE CLOSED WHEN THE PATIENT WAS ENDING THERAPY AND DISCONNECTING. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF ADDITIONAL RELEVANT INFORMATION IS OBTAINED, THEN A FOLLOW-UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A LEAK FROM THEIR TRANSFER SET WHILE PERFORMING PERITONEAL DIALYSIS (PD) THERAPY. THE PATIENT DID NOT SHUT THEIR TWIST CLAMP (NO ADDITIONAL DETAILS PROVIDED). THERE WAS PATIENT INVOLVEMENT; HOWEVER THERE WAS NO PATIENT INJURY, MEDICAL INTERVENTION, OR ADVERSE REACTION INDICATED WITH THE REPORTED CONDITION. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722819 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR DIANEAL 1.5% & 2.5%, EXTRANEAL