BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2211838 · Received August 15, 2011

    Report

    Report Number
    1423500-2011-10719
    Event Type
    Malfunction
    Date Received
    August 15, 2011
    Date of Event
    August 8, 2011
    Report Date
    August 8, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS NOT RETURNED TO BAXTER FOR EVALUATION AND THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED. A CAUSE FOR THE REPORTED ISSUE WAS UNDETERMINED. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED PROBLEM OF INCREASED INTRA-PERITONEAL VOLUME (IIPV). BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THIS ISSUE HAS BEEN ESCALATED TO CAPA.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS NOT AVAILABLE AT THIS TIME. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REQUEST ASSISTANCE ON THE HOME CHOICE (HC). PER THE INITIAL REPORT, THE HOME PATIENT (HP) WAS IN DRAIN 5 OF 5, DRAIN VOLUME 4108ML, AND WAS REQUESTING ASSISTANCE TO BYPASS TO LAST FILL DUE TO DRAIN PAINS. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE PROGRAMMING: FILL VOLUME 1800ML, THE HP HAD NO ALARMS AND NO BYPASSES. THE TSR REFERRED THE HP TO THE PERITONEAL DIALYSIS NURSE (PDN) TO REVIEW THE TARGET UF SETTINGS. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. ON (B)(6) 2011, PRODUCT SURVEILLANCE CONTACTED THE HP'S PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORTED INCREASED INTRA-PERITONEAL VOLUME (IIPV). THE PDN STATED HAS SPOKEN WITH THE HP AND THE HP WAS CONTINUING WITH THERAPY WITH NO OTHER ISSUES. THE PDN STATED THE HP HAS NOT REPORTED ANY OTHER SYMPTOMS OR OTHER DRAIN VOLUMES THAT MEET INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. THE PDN CONFIRMED THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS REPORT AND THAT THE HP WAS DOING WELL WITH THE FOLLOWING TREATMENTS. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. A SWAP WAS OFFERED BUT THE PDN DECLINED STATING THIS WAS MOST LIKELY AN HP ISSUE AND NOT RELATED TO THE DEVICE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR