BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 2991078 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05363
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 14, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS RECEIVED AND EVALUATED. A REVIEW OF THE LOGS REVEALED NO FAILURE, MALFUNCTION OR INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. THE DEVICE PASSED BOTH ELECTRICAL AND FUNCTIONAL TESTING AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION. A REVIEW OF MANUFACTURING RECORDS REVEALED THE DEVICE HAS BEEN REFURBISHED/SERVICED SINCE ITS ORIGINAL MANUFACTURE DATE AND THE DEVICE IS NO LONGER IN ITS ORIGINAL MANUFACTURE CONDITION. THEREFORE, NO MANUFACTURING ISSUES RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. A SERVICE HISTORY REVIEW WAS PERFORMED, REVEALING THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION AND PREVIOUS SERVICING DID NOT CONTRIBUTE TO THE REPORTED CONDITION. THE ISSUE WAS NOT CONFIRMED WITH REGARD TO THE DEVICE. THE CAUSE WAS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS REPORTED TO BE AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Description of Event or Problem · 1

    THIS IS A REPORT OF A HOME PATIENT (HP) WHO EXPERIENCED A PERITONEAL LEAK. PERITONEAL DIALYSIS (PD) THERAPY WAS TEMPORARILY DISCONTINUED. IT WAS REPORTED THE HP WAS RECOVERING FROM THE PERITONEAL LEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95671 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other DIANEAL PD4 AMBUFLEX