BEUDAMED
    FDA Adverse Event Summary report: N

    HOMECHOICE

    MDR report key: 1870018 · Received October 15, 2010

    Report

    Report Number
    1423500-2010-04433
    Date Received
    October 15, 2010
    Product Code
    FKX
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL). THE DEVICE WAS DETERMINED TO MEET FUNCTIONAL AND ELECTRICAL PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE TESTING. THE DEVICE PASSED BOTH THE HOMECHOICE RETURN INSTRUMENT TEST / EVALUATION (RITE) ELECTRICAL TEST AND THE FUNCTIONAL TEST. REVIEW OF THE DEVICE LOGS REVEALED AN ADDITIONAL DIFFICULTY OF AN INCREASED INTRAPERITONEAL VOLUME (IIPV) HAD OCCURRED ON (B)(6) 2010 DURING CYCLE 4. THE IIPV IS BEING ADDRESSED UNDER MANUFACTURER REPORT NUMBER: 1423500-2010-04591. CONTINUED REVIEW OF THE RETURNED DEVICE LOGS REVEALED THE LAST THERAPY PERFORMED USING THE DEVICE WAS INITIATED (B)(6) 2010 ENDING (B)(4) 2010 AND WAS SUCCESSFULLY CONTINUED TO COMPLETION. REVIEW OF THE DEVICE'S PREVIOUS SERVICE RECORD REVEALED NO ISSUES THAT MAY HAVE CONTRIBUTED TO THE PATIENT EXPIRATION. THE ASSIGNABLE CAUSE OF REPORTED INCIDENT WAS UNDETERMINED VIA DEVICE EVALUATION. A LABELING REVIEW WAS PERFORMED AND FOUND TO BE SUFFICIENT. A TREND REVIEW WAS PERFORMED AND 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

    (B)(4).

    Description of Event or Problem · 1

    GLOBAL PHARMACOVIGILANCE PROVIDED INFORMATION THAT THE HOMECHOICE PATIENT HAD EXPIRED ON (B)(6) 2010 DUE TO CONGESTIVE HEART FAILURE (CHF). DURING A FOLLOW UP CALL ON 09/22/10, THE FACILITY NURSE STATED THE PATIENT EXPIRED IN (B)(6) 2010, HOWEVER NO FURTHER INFORMATION WAS AVAILABLE. THE WIFE INDICATED THE HC WAS PICKED UP ON (B)(6) 2010. THE WIFE INDICATED THE CAUSE OF DEATH WAS CHF AND SHE DOES NOT HAVE A DEATH CERTIFICATE. THE NURSE INDICATED THE CAUSE OF DEATH WAS UNRELATED TO THE DEVICE, THERAPY, OR ANY BAXTER SOLUTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOMECHOICE FKX

    Patients

    Seq Age Sex Outcome Treatment
    1 (B)(4) DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%.