BEUDAMED
    FDA Adverse Event Death Summary report: N

    PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED

    MDR report key: 1240472 · Received November 21, 2008

    Report

    Report Number
    1423500-2008-00930
    Event Type
    Death
    Date Received
    November 21, 2008
    Date of Event
    October 5, 2008
    Report Date
    October 27, 2008
    Manufacturer
    BAXTER HEALTHCARE-LARGO
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF DEVICE EVALUATION.

    Description of Event or Problem · 1

    A NURSE CONTACTED PRODUCT SURVEILLANCE TO REPORT A PT DEATH WHILE IN DRAIN 6 OF 6 OF THERAPY ON THE HOMECHOICE (HC) MACHINE. THE HOME PT (HP) EXPIRED IN 2008, WHILE AT HOME. ADDITIONALLY, THE NURSE REPORTED THAT THE EVENT LOG OF THE HC MACHINE REVEALED A CHECK PT LINE ALARM AND A SYSTEM ERROR 2265 DURING THE THERAPY SESSION IN QUESTION. THE HP'S NEPHROLOGIST WOULD LIKE A THOROUGH EVALUATION OF THE HC "TO COVER ALL BASES". THE NURSE STATED THE HP'S WIFE SUSPECTS THE HC MACHINE MIGHT HAVE BEEN INVOLVED IN THE PT DEATH. THE NURSE REPORTED THAT THE HP'S WIFE WAS VERY SHAKEN AFTER FINDING THE HP STILL CONNECTED TO THE MACHINE AND NON-RESPONSIVE. SHE CALLED AN AMBULANCE AND EMERGENCY PERSONNEL DISCONNECTED THE HP FROM THE MACHINE. THE WIFE'S OBSERVATION OF THE PT APPEARING BLOATED (AS REPORTED TO THE NURSE)WAS NOT CONFIRMED BY PARAMEDICS. THE NURSE STATED THE PARAMEDICS REPORT INDICATED THE HP'S ABDOMEN WAS SOFT AND THEY HAD NO TROUBLE INTUBATING. THE HP'S TOTAL THERAPY VOLUME IS 14500ML AND THERE IS USUALLY APPROX 500ML LEFT (AS WAS THE CASE IN THIS THERAPY SESSION). THERE WAS NO NEGATIVE ULTRAFILTRATION OR FLUID RETENTION REPORTED. PER THE NURSE, SHE HAS AN ER REPORT WHICH LISTS "CARDIAC/RESPIRATORY" AS CAUSE OF DEATH. THE ENTIRE SET-UP FROM THE THERAPY BEING PERFORMED AT THE TIME OF THE HP'S DEATH IS STILL CONNECTED TO THE HC MACHINE. THE NURSE WOULD LIKE TO LEAVE THE SET-UP "AS IS" AND RETURN IT TO BAXTER. THE NURSE ALSO REQUESTED THE RESULTS OF EVALUATION. THE NURSE STATED THAT IN HER OPINION, THE HP'S DEATH IS UNRELATED TO THE HC MACHINE OR DIANEAL SOLUTION. THE FOLLOWING MONTH, PRODUCT SURVEILLANCE SPOKE WITH THE HP'S SPOUSE WHO GAVE THE FOLLOWING INFO: THE HP'S THERAPY STARTED AS NORMAL BY CONNECTING TO THE HC MACHINE. THE MORNING OF THE HP'S DEATH THE HC MACHINE STARTED BEEPING AND SHE NUDGED HER SPOUSE IN THE SIDE AND REALIZED HE WAS AS HARD AS A ROCK. SHE LOOKED AT HIM AND HIS CHEST/RIB CAGE LOOKED BLOWN UP AND LARGE. SHE STATED THAT THE HP'S STOMACH WAS ALSO HARD AND LOOKED LARGE. THE HP'S WIFE GRABBED THE HP FROM BEHIND AND HE WAS STILL WARM YET HE WAS UNRESPONSIVE. THE HC MACHINE WAS IN DRAIN 6 OF 6 AND THE DISPLAY READ, "MALFUNCTION ERROR". THE WIFE DID NOT KNOW IF THERE WERE ANY NUMBERS ON THE DISPLAY ALONG WITH THE MALFUNCTION ERROR MESSAGE. SHE WAS TAUGHT THAT IF THE HC MACHINE WAS ALARMING THEN SOMETHING WRONG WITH THE HC MACHINE AND SHE WANTS THE HC EVALUATED. THE HP'S WIFE STATED THE DEATH CERTIFICATE NOTED NATURAL CAUSES AS THE PRIMARY CAUSE OF DEATH AND IT ALSO SAID SOMETHING ABOUT PULMONARY/RESPIRATORY. AN AUTOPSY WAS NOT PERFORMED, AS THE HP'S WIFE DID NOT WANT ONE PERFORMED. SHE STATED SHE IS NOT COMFORTABLE WITH THE WAY THE PERITONEAL DIALYSIS (PD) NURSE SET THE HC MACHINE UP FOR THERAPY BECAUSE THEY HAD A LOT OF PROBLEMS DURING THE INITIAL DRAIN CYCLE. IN PREVIOUS EXPERIENCES WITH THE HC MACHINE, THE MACHINE WOULD NOT PULL THE HP'S FLUID OUT DURING INITIAL DRAIN AND THE HC MACHINE WOULD START THE FILL CYCLE. THE HP WOULD STOP THE HC MACHINE, DISCONNECT, AND PERFORM A MANUAL DRAIN BECAUSE HE DID NOT FEEL THAT THE HC MACHINE WAS DRAINING PROPERLY. THE HP WAS SCHEDULED FOR A VEIN MAPPING THE FRIDAY FOLLOWING HIS DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PD CYCLER 110 VOLT HOMECHOICEPRO AUTOMATED 78FKX FKX BAXTER HEALTHCARE-LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death