BEUDAMED
    FDA Adverse Event Death Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1939954 · Received December 28, 2010

    Report

    Report Number
    1423500-2010-07329
    Event Type
    Death
    Date Received
    December 28, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING INVESTIGATION BY BAXTER THIS INCIDENT WAS DETERMINED TO BE CAUSED BY USE/USER ERROR AND THERE WAS NO ALLEGATION OF A PRODUCT MALFUNCTION. THEREFORE, THE DEVICE WAS NOT REQUESTED FOR EVALUATION AND A BATCH REVIEW WILL NOT BE CONDUCTED. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). ON (B)(6) 2010, THE PERITONEAL DIALYSIS NURSE (PDRN) REPORTED TO BAXTER THAT THE HOME PATIENT(HP) HAD DIED. ON AN UNREPORTED DATE, THE HP BEGAN TREATMENT WITH DIANEAL PD2 AMBUFLEX INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). THE CAUSE OF DEATH WAS NOT REPORTED. IT WAS NOT REPORTED WHETHER AN AUTOPSY WAS PERFORMED. PD THERAPY WAS ONGOING AT THE TIME OF THE HP'S DEATH. THE HP PREVIOUS TO DEATH EXPERIENCED FLUID OVERLOAD, WEIGHT INCREASING, EDEMATOUS, ABSORBING FLUID, AND THE PD CATHETER HAD MIGRATED IN 2010. ON (B)(6) 2011, FURTHER INFORMATION WAS OBTAINED FROM THE PDRN. ON AN UNREPORTED DATE IN 2010, THE HP EXPERIENCED SEPSIS. ON (B)(6) 2010, THE HP DIED AS A RESULT OF THE SEPSIS. THE CAUSE OF THE SEPSIS WAS UNKNOWN. TREATMENT ADMINISTERED WAS NOT PROVIDED PRIOR TO DEATH. ACCORDING TO THE PDRN, THE EVENT OF FATAL SEPSIS WAS NOT RELATED TO PD THERAPY. ON (B)(6) 2011, AN ENGINEERING QUALITY REVIEW WAS PERFORMED FOR THIS REPORT OF PATIENT DEATH. A CASUAL RELATIONSHIP WAS NOT REPORTED FOR THE EVENT OF DEATH. THERE IS NO EVIDENCE THAT THE DEVICE OR DISPOSABLES WERE CAUSALLY RELATED TO THIS EVENT. THE LABELING REVIEW FOUND THE LABELING ADEQUATE FOR THE USE ERROR IN THIS COMPLAINT SPECIFIC TO THE 2240 ALARM, AS PATIENTS ARE INSTRUCTED TO CLOSE ALL CLAMPS ON UNUSED FLUID LINES SECURELY.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 WAS NOT CONFIRMED DUE TO THE LACK OF A SAMPLE; HOWEVER, BASED ON THE INFORMATION GATHERED DURING BAXTER'S INVESTIGATION, THE CAUSE OF THE SYSTEM ERROR 2240 WAS DUE TO AIR BEING SUCKED INTO THE DISPOSABLE AFTER A PATIENT LEFT A CLAMP OPEN ON AN UNUSED SUPPLY LINE. THE LOT INFORMATION WAS UNKNOWN; THEREFORE A BATCH REVIEW WAS NOT PERFORMED. REVIEW OF THE LABELING REVEALS THE HOMECHOICE APD SYSTEMS AT-HOME GUIDE CONTAINS SUFFICIENT LABELING FOR THE USER ERROR IN THIS COMPLAINT. BAXTER HAS RECEIVED SIMILAR REPORTS. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    A PATIENT CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING ASSISTANCE WITH A SYSTEM ERROR 2240 WHILE USING THE HOMECHOICE (HC) DURING THE INITIAL DRAIN. GTS EXPLAINED THAT A LARGE AMOUNT OF AIR HAD ENTERED INTO THE DISPOSABLE SET AND HAD THE PATIENT CYCLE POWER TO START OVER WITH NEW SUPPLIES. GTS THEN REVIEWED PROPER PROCEDURES WITH THE PATIENT AS A CLAMP WAS FOUND TO BE OPEN ON AN UNUSED SUPPLY LINE. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AUTOMATED PD SET W/CASSETTE4 PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| O HOMECHOICE APD CYCLER (B)(4) (REFURBISHED)