BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1891189 · Received November 4, 2010

    Report

    Report Number
    1423500-2010-05241
    Event Type
    Death
    Date Received
    November 4, 2010
    Date of Event
    January 12, 2010
    Report Date
    March 5, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE BAXTER PRODUCT ANALYSIS LAB ( PAL) INDICATED: THE DEVICE WAS RECEIVED AND ROUTED TO SERVICE PRIOR TO THE PRODUCT ANALYSIS LABORATORY (PAL) BEING NOTIFIED OF THE COMPLAINT STATUS. THE REASON FOR DISCONTINUED USE OF THE DEVICE BY THE CUSTOMER WAS DETERMINED TO BE THAT THE CUSTOMER IS DECEASED. THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST AND EVALUATION (RITE) ELECTRICAL TEST AND THE RITE FUNCTIONAL TEST. REVIEW OF THE RETURNED DEVICE LOGS WERE ALL SUCCESSFULLY CONTINUED TO COMPLETION. REVIEW OF THE RETURNED DEVICE LOGS REVEALED NO PATIENT DRAIN VOLUMES THAT MET OR EXCEEDED THE INCREASED INTRAPERITONEAL VOLUME (IIPV) CRITERIA. REVIEW OF THE DEVICE?S PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE PATIENT PASSING AWAY. THE ASSIGNABLE CAUSE OF THE REPORTED INCIDENT WAS UNDETERMINED. NO DEVICE FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE PATIENT PASSING AWAY. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE HOMECHOICE DEVICE HAS BEEN RETURNED TO BAXTER PRODUCT ANALYSIS LAB FOR EVALUATION. BAXTER IS IN THE PROCESS OF INVESTIGATING THIS EVENT. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED THAT DURING TESTING AT THE USER FACILITY, THE DEVICE DID NOT ALARM WHEN AIR WAS IN THE TUBING DISTAL TO THE DEVICE. THERE WERE NO REPORTS OF ANY ADVERSE PT EVENTS AND NO REPORTED DELAYS OF CRITICAL THERAPIES WHILE THE DEVICE WAS IN CLINICAL USE. THOUGH REQUESTED, NO ADD'L INFO WAS PROVIDED.

    Description of Event or Problem · 1

    BAXTER'S GLOBAL PHARMACOVIGILANCE DEPARTMENT INITIALLY RECEIVED NOTIFICATION OF THE PATIENT DEATH ON (B)(6) 2010 AND ATTEMPTS WERE MADE TO OBTAIN ADDITIONAL INFORMATION FROM FRESENIUS WITHOUT SUCCESS. THE NURSE DECLINED TO PROVIDE FURTHER INFORMATION, ON (B)(6) 2010, BAXTER RECEIVED LITIGATION DOCUMENTATION FROM THE PATIENT'S ATTORNEY INDICATING THAT THE PATIENT WAS USING A HOMECHOICE PRO DEVICE FOR PERITONEAL DIALYSIS. THE PATIENT REPORTEDLY EXPIRED ON (B)(6) 2010 FROM COMPLICATIONS ASSOCIATED WITH USE OF THE HOMECHOICE DEVICE THAT HE HAD BEEN USING FOR APPROXIMATELY ONE YEAR. THE PATIENT REPORTEDLY HAD RECEIVED THE DEVICE THROUGH (B)(6). REPORTEDLY, THE FAMILY RELINQUISHED THE HOMECHOICE DEVICE TO A REPRESENTATIVE OF (B)(6) IN (B)(6) 2010.

    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 76 YR Death