BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1863874 · Received October 11, 2010

    Report

    Report Number
    1423500-2010-04267
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 4, 2010
    Report Date
    September 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). REVIEW OF THE DEVICE HISTORY RECORDS IDENTIFIED NO EXCEPTION DURING MANUFACTURING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS INCIDENT. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. AS A RESULT, A ROOT CAUSE FOR THE REPORTED DIFFICULTIES COULD NOT BE DETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH CAPA (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN INDICATED THAT THE DEVICE IS AVAILABLE FOR EVALUATION BUT HAS NOT BEEN RECEIVED AS OF YET. IF THE DEVICE IS RECEIVED FOR EVALUATION, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM THE PATIENT'S NURSE ON (B)(6) 2010 REGARDING RETURN OF THE HOMECHOICE (HC) DEVICE FOR EVALUATION. THE NURSE INDICATED THAT AS THE PATIENT WANTED TO TRY PERITONEAL DIALYSIS (PD) THERAPY AGAIN, HE WAS SWITCHED BACK TO PD THERAPY FROM HEMODIALYSIS, IS USING THE SAME HC DEVICE, AND HAS BEEN ABLE TO CONTINUE WITH PD THERAPY WITHOUT ANY FURTHER ISSUES. THEREFORE, THE PATIENT WILL CONTINUE USING THE SAME HC DEVICE AND IT WILL NOT BE RETURNED. NO FURTHER INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER TO REPORT RECEIVING A LOW DRAIN VOLUME ALARM ON THE HOMECHOICE (HC) MACHINE DURING THE INITIAL DRAIN, DRAIN VOLUME (DV) 172ML, LAST FILL VOLUME (LFV) 2000ML, INITIAL DRAIN ALARM (IDA) 1800ML. PER THE INITIAL REPORT, THE HOME PATIENT (HP) STATED THE REGISTERED NURSE (RN) STARTED HIM ON EXTRANEAL FOR THE FINAL FILL. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) CONFIRMED THE HP COMPLETED THE PREVIOUS THERAPY. THE TSR HAD THE HP CHECK THE PATIENT LINE FOR KINKS, FIBRIN, AIR, OR CLOSED CLAMPS AND THEY ALL WERE CLEAR. THE TSR HAD THE HP CLOSE THEN OPEN THE TRANSFER SET FIVE TIMES. THE HP REPOSITIONED AND RESUMED THE DRAIN. THE DV WENT BACK TO 156ML THEN 169ML. THE HP THEN STATED HE FELT BLOATED. THE TSR EXPLAINED TO THE HP THE TSR WAS UNABLE TO DO A TEST FILL AND DRAIN BECAUSE OF THE BLOATED FEELING. THE HP STATED HE WOULD GET OFF THE HC AND TRY TO DRAIN MANUALLY. THE HP WOULD ALSO CONTACT THE RN FOR ADVICE. ON (B)(4) 2010, PRODUCT SURVEILLANCE CONTACTED THE HP PERITONEAL DIALYSIS NURSE (PDN) REGARDING THE REPORT OF FEELING BLOATED. THE PDN STATED THE HP HAD A LEAK FROM THE PERITONEUM INTO THE SUBCUTANEOUS TISSUE. THE PDN STATED THE HP IS STARTING HEMODIALYSIS ON THIS DAY AND IS UNLIKELY TO RETURN TO PERITONEAL DIALYSIS. THERE WERE NO ALLEGATIONS MADE AGAINST ANY OF THE HP'S DIALYSIS PRODUCTS. DURING A FOLLOW-UP CALL TO THE PDN, THE PDN INDICATED THAT THE PATIENT HAD NOT HAD ANY INSTANCES OF INCREASED INTRAPERITONEAL VOLUMES (IIPV). THE PDN INDICATED THAT SHE IS GOING TO ARRANGE FOR THE PICKUP OF THE HOMECHOICE DEVICE AS THE PATIENT IS ONLY ON HEMODIALYSIS NOW AND IS DOING WELL. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention