BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1760047 · Received July 16, 2010

    Report

    Report Number
    1423500-2010-01518
    Event Type
    Injury
    Date Received
    July 16, 2010
    Date of Event
    June 25, 2010
    Report Date
    June 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF THE PREVIOUS SERVICE RECORD ((B)(4) 2008) FOR HOMECHOICE S/N (B)(4) WAS PERFORMED ON (B)(4) 2010. THE DEVICE PASSED ALL REQUIRED TESTS AND CALIBRATIONS PRIOR TO BEING RELEASED FROM (B)(4) FACILITY. DURING SERVICE OF THIS DEVICE THE PARTS REPLACED PER NORMAL SERVICE ACTIVITIES WERE NOT RELATED TO THE REPORTED PROBLEM OF PATIENT SYMPTOM. EVALUATION SUMMARY: WHEN RECEIVED, THE DEVICE HAD THE FOLLOWING PARAMETERS PROGRAMMED: THERAPY: CONTINOUS CYCLING PERITONEAL DIALYSIS (CCPD) INTERMITTENT PD, THERAPY VOLUME: 12000, THERAPY TIME: 9:00, FILL VOLUME: 2700, LAST FILL VOLUME: 1000, INITIAL DRAIN ALARM: OFF, CYCLES: 4, CALCULATED DWELL: 01:40, DRAIN VOLUME PERCENT: 85, LAST MANUAL DRAIN: NO. THE DEVICE PASSED THE HOME CHOICE RETURNED INSTRUMENT TEST EVALUATION (RITE) AND THE ELECTRICAL LEAKAGE TEST. EXTERNAL VISUAL INSPECTIONS PERFORMED REVEALED NO PROBLEMS. THE PATIENT'S THERAPY EVENT LOG CONTAINED PATIENT THERAPY DATA FROM (B)(6) 2010 AND RECORDED NO DEVICE ANOMALIES AND NO INSTANCES OF INCREASED INTRAPERITONEAL VOLUMES (IIPV). THE LOG SHOWS THAT THE LAST THERAPY ATTEMPTED WAS ABORTED DURING DRAIN 2 AFTER THE DEVICE ALARMED CHECK PATIENT LINE WITH A PATIENT VOLUME OF 2699 ML. THE DEVICE WAS THEN TURNED OFF AND THE THERAPY ABORTED. THE THERAPY LOG RECORDED THERAPY INFORMATION FROM (B)(6) 2010 AND RECORDED THAT 4 OF THE LAST 6 THERAPIES PERFORMED HAD POSITIVE TOTAL ULTRAFILTRATIONS (UFS) WITH THE LAST THERAPY BEING NEGATIVE AND ABORTED. THE ALARM LOG RECORDED PATIENT ALARMS FROM (B)(6) 2010 AND HAD RECORDED CHECK LINES AND BAGS, CHECK PATIENT LINE AND SYSTEM ERROR (SE) 2084 ALARMS. A CHECK LINES AND BAGS ALARM WILL OCCUR WHEN ONE OR MORE OF THE LINES ARE CLOSED OR SOLUTION BAGS ARE EMPTY. A CHECK PATIENT LINE ALARM WILL OCCUR WHEN THE PATIENT LINE IS CLOSED DUE TO A KINK, CLOSED CLAMP OR FIBRIN BLOCKAGE. A SE 2084 (ILLEGAL DOOR OPEN) WILL OCCUR WHEN THE DOOR WAS OPENED WHILE THE DEVICE WAS PUMPING FLUID. A REVIEW OF THE CYCLE BY CYCLE UF LOG REVEALED NO UFS THAT EXCEEDED THE IIPV CRITERIA. THE REPORTED CONDITION OF PAIN WAS UNABLE TO BE CONFIRMED IN THE LOGS OR DUPLICATED DURING THE PRODUCT ANALYSIS LABORATORY (PAL) EVALUATION. ISSUES SUCH AS WERE REPORTED ARE PATIENT SYMPTOM IN NATURE AND WOULD NOT BE RECORDED IN THE LOGS OR DUPLICATED DURING THE PAL EVALUATION. THE ASSIGNABLE CAUSE WAS UNDETERMINED. THE PAL EVALUATED THE DEVICE AND NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. THE DEVICE WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A HOME PATIENT'S (HP) PERITONEAL DIALYSIS NURSE (PD RN) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT HP WAS STATING THAT HE WAS OVERFILLED. THE RN STATED THAT THE HP WAS IN THE HOSPITAL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASKED IF THE HP HAD SYMPTOMS AND THE NURSE STATED HE DID NOT. THE RN STATED THAT HE REVIEWED THE SETTINGS AND THE INITIAL DRAIN ALARM (IDA) AND IT WAS SET TO OFF. THE TSR REVIEWED THE THERAPY SETTINGS, THERAPY LOG AND ULTRAFILTRATION (UF) PER CYCLE. THE RN STATED THAT HE CHANGED THE IDA TO 500 MILLILITERS (ML). THE THERAPY SETTINGS WERE IDENTIFIED WITH THE NURSE. THE TSR ASKED THE RN WHY THE HP WAS IN THE HOSPITAL AND THE RN INDICATED IT WAS BECAUSE THE HP WAS FEELING SO FULL. THE TSR ASKED THE RN IF HE WOULD LIKE TO HAVE THE HOMECHOICE (HC) DEVICE SWAPPED AND THE RN STATED YES. THE RN STATED THAT HE WOULD ASSIST THE HP WITH THE HC PROGRAMMING. FOLLOW-UP WAS PERFORMED WITH THE RN BY PRODUCT SURVEILLANCE REGARDING THE PATIENT FEELING FULL. THE RN STATED THAT THE HP WAS IN THE HOSPITAL FOR RIGHT FLANK PAIN. THE NURSE STATED THAT THE HP HAD DRAINED 790ML AND THAT THE LPFV WAS 2700ML. THE NURSE STATED THAT THE PATIENT FILLED, DRAINED AND THEN TURNED THE CYCLER OFF TO GO TO THE HOSPITAL. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE HP'S PD RN ON (B)(4) 2010: THE RN INDICATED THAT THE HP'S RIGHT FLANK PAIN WAS CAUSED BY PROBLEMS THE HP WAS HAVING WITH HIS RIGHT KIDNEY. A STENT WAS PLACED ON THE HP AND THEN THE HP'S RIGHT KIDNEY WAS RECENTLY REMOVED AFTER THE STENT DID NOT IMPROVE THE HP'S PAIN. THE RN INDICATED THAT THE HP'S PD THERAPY DID NOT AGGRAVATE THE HP'S CONDITION BUT THAT THE HP WAS PLACED ON SUPPLEMENTAL HEMODIALYSIS AS THEY DID NOT WANT TO PUT ANY EXTRA PRESSURE ON THE HP'S SUTURES. THE HP WILL BE ON HEMODIALYSIS FOR LESS THAN 30 DAYS AND WILL RETURN TO PD THERAPY. THE RN CONFIRMED THAT THE HP WAS NOT OVERFILLED AND THAT THE HP'S REGULAR THERAPY VOLUMES WERE JUST PUTTING PRESSURE ON HIS KIDNEY. THE RN INDICATED THAT THE HP'S RIGHT FLANK PAIN HAS RESOLVED AND THE PATIENT IS DOING FINE. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    CALLER STATES, THE PATIENT TESTED 4.4 INR ON THE COAGUCHEK S SYSTEM AND 3.2 INR ON A COMPARISON LAB. NO TREATMENT INFORMATION PROVIDED. NO ADVERSE EVENT REPORTED. REQUESTED RETURN OF SUSPECT SYSTEM, HOWEVER, STRIPS ARE UNAVAILABLE FOR RETURN. REPLACEMENT WAS SENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R