BEUDAMED
    FDA Adverse Event Death Summary report: N

    HOMECHOICE

    MDR report key: 2232938 · Received September 2, 2011

    Report

    Report Number
    1423500-2011-11629
    Event Type
    Death
    Date Received
    September 2, 2011
    Date of Event
    July 30, 2011
    Report Date
    July 30, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE FOR THE REPORTED CONDITION OF PATIENT DEATH WAS UNDETERMINED. THE DEVICE FAILED THE HOMECHOIDE RETURN INSTRUMENT TEST/EVALUATION FUNCTIONAL DUE TO ENCOUNTERING A RELOAD SET 153 (POSITIVE (POST) TANK PRESSURE LEAK / 1.0 PSI OR MORE LOSS IN POST IN 5 SECONDS). THE HOMECHOICE RITE ELECTRICAL TEST PASSED WITH NO PROBLEMS ENCOUNTERED. NO FAILURE OR MALFUNCTION WAS IDENTIFIED THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED CONDITION. A SERVICE HISTORY REVIEW WAS CONDUCTED, WHICH REVEALED THE DEVICE HAD FAILED HOMECHOICE FINAL TEST & CALIBRATION FOR LEAK TEST DURING A PREVIOUS SERVICE EVENT. THE DEVICE WAS REWORKED AND PASSED ALL TESTS PRIOR TO ITS RELEASE. 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.

    Description of Event or Problem · 1

    THE CAREGIVER (CG) CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING ASSISTANCE WITH AN OVERFILLED DRAIN BAG ISSUE, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE, DURING INITIAL DRAIN. DRAIN VOLUME (DV) EQUALED 2441ML. THE CG STATED THAT THE BAGS WERE FILLING WITH WASTE SOLUTION AND THAT THE HOME PATIENT (HP) HAD BEEN HAVING DRAIN ISSUES. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) HAD THE CG CLOSE ALL CLAMPS, DISCONNECT THE HP FORM THE HC AND CYCLE POWER. THE HC ALARMED POWER RESTORED/INITIAL DRAIN-DV EQUALED 2441. THE TSR ASSISTED THE CG WITH ENDING THERAPY AND REMOVING THE SET. THE TSR INSTRUCTED THE CG TO START OVER WITH NEW SUPPLIES AND REPORT THE PROBLEM TO HP'S PERITONEAL DIALYSIS NURSE (PDRN) IN THE MORNING. THE TSR ASSISTED THE CG WITH ENDING THE THERAPY AND REMOVING THE SET. THE HC WAS OPERATIONAL. THE SOLUTION TO THIS ISSUE WAS PROVIDED OVER THE PHONE AND A SWAP OF THE DEVICE WAS NOT NECESSARY. THERE WAS PATIENT INVOLVEMENT, BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. DURING A FOLLOW-UP CALL FOR AN UNRELATED ISSUE, THE PERITONEAL DIALYSIS (PD) NURSE REPORTED THE HOME PATIENT (HP) RECENTLY EXPIRED. ADDITIONAL INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE. ON AN UNREPORTED DATE, THE HP BEGAN PERITONEAL DIALYSIS (PD) WITH DIANEAL LOCAL (PD4) AMBUFLEX INTRAPERITONEALLY (IP) NIGHTLY. ON (B)(6) 2011, THE HP DIED AT HOME. THE PD NURSE STATED THAT THE CAUSE OF DEATH WAS CARDIAC RELATED. NO DEATH CERTIFICATE WAS AVAILABLE AT TIME OF CALL. AT THE TIME OF DEATH, THE HP WAS ON HOSPICE CARE DUE TO CARDIOMYOPATHY AND CONGESTIVE HEART FAILURE. THE HP RECEIVED PD THERAPY WITH THE HOMECHOICE UP UNTIL THE TIME OF DEATH. THE PD NURSE STATED THAT THE DEATH WAS UNRELATED TO PD THERAPY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death DIANEAL LOCAL