BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE PRO

    MDR report key: 2402591 · Received January 6, 2012

    Report

    Report Number
    1423500-2012-00457
    Event Type
    Death
    Date Received
    January 6, 2012
    Report Date
    December 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION BY THE BAXTER PRODUCT ANALYSIS LAB (PAL). UPON COMPLETION OF THE EVALUATION OR SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE HOMECHOICE WAS RETURNED AND EVALUATED BY THE BAXTER PRODUCT ANALYSIS LABORATORY (PAL) FOR THE REPORTED DIFFICULTY OF HOME PATIENT PASSED AWAY. THE DEVICE PASSED BOTH THE HOMECHOICE RITE ELECTRICAL TEST AND THE HOMECHOICE RITE FUNCTIONAL TEST AND WAS DETERMINED TO MEET PERFORMANCE SPECIFICATION REQUIREMENTS PER RITE (RETURNED INSTRUMENT TEST EVALUATION) TESTING. REVIEW OF THE DEVICE EVENT LOG DID NOT REVEAL ANY FAILURES, MALFUNCTIONS OR IIPV EVENTS THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED DIFFICULTY. REVIEW OF THE DEVICE HISTORY RECORD REVEALED A FAILED VOLUMETRIC CALIBRATION. THE DEVICE WAS RETESTED AND PASSED ALL SUBSEQUENT TESTING PRIOR TO ITS RELEASE. NO ISSUES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE OF A PATIENT DEATH. THE REPORTED ISSUE WITH REGARDS TO THE DEVICE WAS NOT CONFIRMED. THE ASSIGNABLE CAUSE WAS NOT DETERMINED.

    Description of Event or Problem · 1

    INITIALLY, BAXTER PRODUCT SURVEILLANCE (PS) CONTACTED THE CUSTOMER TO FOLLOW UP ON A CALL THE CUSTOMER HAD MADE TO BAXTER TECHNICAL SERVICE REGARDING AN UNRELATED CHECK HEATER LINE ALARM WHICH OCCURRED ON THE HOMECHOICE DEVICE DURING USE FOR PERITONEAL DIALYSIS THERAPY. DURING THE CONVERSATION, PS WAS INFORMED BY THE CAREGIVER (CG) THAT THE PATIENT HAD PASSED AWAY. MULTIPLE ATTEMPTS WERE MADE TO OBTAIN FURTHER INFORMATION. ON (B)(6) 2012, THE REGISTERED NURSE (RN) RETURNED PRODUCT SURVEILLANCE'S CALL. THE RN STATED SHE COULD NOT RELEASE ANY INFORMATION ABOUT THE PATIENT'S DEATH PER THE CLINIC'S POLICY. THERE WAS NO REPORT OF AN ALLEGATION AGAINST A BAXTER PRODUCT OR SOLUTION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Death