BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE PRO

    MDR report key: 3002960 · Received March 13, 2013

    Report

    Report Number
    1416980-2013-06082
    Event Type
    Malfunction
    Date Received
    March 13, 2013
    Date of Event
    February 25, 2013
    Report Date
    February 25, 2013
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF AN IIPV. THE DEVICE IS NOT AVAILABLE AT THIS TIME. A FOLLOW-UP MDR WILL BE SUBMITTED IF ANY RELEVANT ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE DEVICE IS NO LONGER IN ITS ORIGINAL MANUFACTURE CONDITION AND ADDITIONAL MANUFACTURE RECORD REVIEW IS NOT REQUIRED. REVIEW OF THE DEVICE SERVICE HISTORY REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY OF IIPV-ADULT. THE CAUSE OF THE IIPV-ADULT WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THIS IS A REPORT OF AN INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT, WHICH OCCURRED ON THE HOMECHOICE (HC) MACHINE DURING PERITONEAL DIALYSIS WHILE THE PATIENT WAS CONNECTED IN DRAIN. THE CAREGIVER (CG) REPORTED THE DRAIN VOLUME, IN DRAIN 3 OF 4, EQUALED 3700ML. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROGRAMMING AND THE LARGEST PRESCRIBED FILL VOLUME WAS 2000ML. THE HOME PATIENT (HP) DID NOT HAVE ANY SYMPTOMS AND THE TSR ADVISED THE CG TO LET THE REGISTERED NURSE KNOW ABOUT HIGH DRAIN VOLUME. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105419 HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR