BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMECHOICE

    MDR report key: 2091719 · Received May 17, 2011

    Report

    Report Number
    1423500-2011-06080
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    April 30, 2011
    Report Date
    April 30, 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 DEVICE HAS BEEN RECEIVED, AND THE EVALUATION IS IN PROCESS. A FOLLOW-UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION IS RECEIVED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE (HC) DEVICE WAS RECEIVED FOR EVALUATION AT THE PRODUCT ANALYSIS LAB (PAL). A REVIEW OF THE DEVICE LOGS CONFIRMED THE INCREASED INTRA-PERITONEAL VOLUME (IIPV) EVENT AND NOT DUPLICATED DURING THE PAL EVALUATION. A CAUSE OF THE IIPV WAS UNKNOWN. THIS DEVICE WAS RETURNED TO (B)(4) AFTER A LARGE DRAIN VOLUME WAS IDENTIFIED BY BAXTER. UPON RETURN, THE HC CYCLER WAS OBSERVED TO ACCURATELY DELIVER FLUID IN A SIMULATED NORMAL THERAPY. EXAMINATION OF THE LOGS SHOWED THAT THERE WAS A LIKELY A RESTRICTION ON THE DRAIN LINE. WHEN A RESTRICTION WAS ADDED TO THE SETUP, A SIGNIFICANT VOLUMETRIC ACCURACY DIFFERENCE WAS OBSERVED. USING HITT, THE LOW FLOW DESTINATION (DRAIN LINE) ERROR WAS INTERRUPTED BY A "LOW FLOW SOURCE" AND "NO ERROR" PUMP ERRORS. THESE ERRORS WERE UNEXPECTED, AND IT IS THOUGHT THAT THEY ARE RESPONSIBLE FOR DEFEATING THE SLOW FLOW DRAIN ALARM TIMER. IN ADDITION, THE DRAIN LINE CLAMP CAUSED THE CYCLER TO TRANSFER FLUID TO THE DRAIN LINE SLOWLY. THIS EFFECTIVELY EXTENDS THE TIME DIALYSATE DWELLS IN THE HOME PATIENT'S PERITONEAL CAVITY AND CAN INCREASE UF. THE ROOT CAUSE OF THE 11,414ML DRAIN VOLUME IS UNKNOWN; HOWEVER, THE CYCLER WAS ABLE TO DELIVER FLUID ACCURATELY IN A NORMAL THERAPY SETUP. A SERVICE HISTORY REVIEW (SHR) REVEALED THAT NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE 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.

    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) WANTED TO BYPASS TO FILL 2. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) REVIEWED THE THERAPY. THE HP STATED THE DRAIN VOLUME WAS 11414ML. THE TSR REVIEWED THE PROGRAMMING: FILL VOLUME 2000ML. THE HP STATED SHE FELT FINE. THE TSR ADVISED WOULD NEED TO END THERAPY AND SWAP THE HC. THE TSR ADVISED TO MAKE THE REGISTERED NURSE (RN) AWARE. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THIS EVENT MEETS OVERFILL CRITERIA. 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 THE HP CALLED AND STATED SHE WAS HAVING SOME TECHNICAL PROBLEMS WITH THE HC DEVICE AND HAD CALLED (B)(6) TO HAVE THE HC DEVICE SWAPPED. THE PDN STATED SHE HAS SPOKEN WITH THE HP AND THE HP HAS NOT HAD ANY ISSUES WITH THE NEW HC DEVICE. 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.

    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