BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1872981 · Received October 18, 2010

    Report

    Report Number
    1423500-2010-04559
    Event Type
    Injury
    Date Received
    October 18, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 12, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS DISCARDED THEREFORE, NO EVALUATION WAS PERFORMED. THE LOT NUMBER IS UNKNOWN, THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. SHOULD ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CHECK LINES AND BAGS WAS NOT CONFIRMED IN THE LAB DUE TO A LACK OF SAMPLE. NO LOT NUMBER IS KNOWN THEREFORE A BATCH REVIEW CANNOT BE PERFORMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT THE PT HAD BEEN EXPERIENCING INTERMITTENT YELLOW BATTERY ALARMS DESPITE HAVING FULLY CHARGED BATTERIES. THE SUSPECT SYSTEM CONTROLLER WAS EXCHANGED AND THE PT REMAINS ON LVAD SUPPORT WITH NO FURTHER ISSUE REPORTED.

    Description of Event or Problem · 1

    GLOBAL TECHNICAL SERVICES RECEIVED A PATIENT CALL REGARDING A CHECK LINES AND BAGS ALARM ON THE HOMECHOICE (HC) UNIT DURING USE. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HOME PATIENT TO RESUME THERAPY. DURING A FOLLOW UP CALL ON (B)(6)2010, THE PATIENT'S DAUGHTER INDICATED THE HOME WAS IN THE HOSPITAL TO HAVE A SHUNT PLACED FOR HEMODIALYSIS THERAPY. THE DAUGHTER INDICTED THE PATIENT WAS HAVING ISSUES WITH "LINING' (UNIDENTIFIED) LEADING TO COMPLICATIONS WITH PERITONEAL DIALYSIS THERAPY. A FOLLOW UP CALL WAS MADE TO THE FACILITY NURSE ON (B)(6) 2010. THE NURSE STATED THE PATIENT HAD ADVISED THE CLINIC ABOUT THE ISSUE BUT THAT THEY WERE ABLE TO START OVER WITH NEW SUPPLIES. THE NURSE WAS UNABLE TO PROVIDE INFORMATION REGARDING THE ALARM. REPORTEDLY, THE PATIENT WENT TO CHICAGO AND WHILE THERE SHE WAS HOSPITALIZED. THE NURSE INDICATED THEY BELIEVE THE PATIENT HAD ISSUES RELATED TO MEMBRANE FAILURE OR A TEAR IN THE MEMBRANE. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010 AND WAS RELEASED (B)(6) 2010. THE PATIENT WAS MOVED TO HEMODIALYSIS. THE NURSE AND NEPHROLOGIST INDICATED THE PATIENT WAS UNDER A LOT OF STRESS BUT WERE NOT SURE STRESS CONTRIBUTED TO THE HOSPITALIZATION. THE NURSE SAW THE PATIENT RECENTLY, AND THE PATIENT INDICATED SHE WAS DOING FINE AND WANTED TO RETURN TO PD. THE NURSE SAID THAT THE MEMBRANE ISSUE SEEMS TO BE A REOCCURRING ISSUE WITH THE PATIENT. IN THE PAST, THE PATIENT HAS BEEN TRANSFERRED TO HEMODIALYSIS THEN RETURNS TO PERITONEAL DIALYSIS (PD). THE NEPHROLOGIST HAS INDICATED IF ISSUES OCCUR AGAIN THE PATIENT WILL LIKELY BE MAINTAINED ON HEMODIALYSIS. INFORMATION RECEIVED FROM BAXTER'S GLOBAL PHARMACOVIGILANCE (GPV) ON 23SEP2010 INDICATES: ON (B)(6)2007, THE PATIENT BEGAN PD THERAPY. AT THE TIME OF THE EVENT, THE PATIENT WAS PERFORMING PD THERAPY WITH 12L OF PD4 AMBUFLEX NIGHTLY AND WITH A FINAL FILL OF 2.4L OF EXTRANEAL. THE NURSE STATED THE PATIENT REMAINED DRY FOR 8 TO 10 HOURS DURING THE DAY. ON AN UNKNOWN DATE IN 2010, THE PATIENT DEVELOPED A PERITONEAL LEAK. AT THE TIME OF THE EVENT, PD THERAPY WAS TEMPORARILY STOPPED AND THE PATIENT WAS STARTED ON HEMODIALYSIS. ON AN UNKNOWN DATE IN 2010, THE PERITONEAL LEAK WAS RESOLVED AND THE PATIENT RESUMED PD THERAPY. IN (B)(6)2010, THE PATIENT DEVELOPED EDEMA IN HER TORSO AND LEGS. ON (B)(6)2010, THE PATIENT WAS HOSPITALIZED FOR EDEMA IN TORSO AND LEGS. ADMITTING DIAGNOSIS WAS A PERITONEAL LEAK. PD THERAPY WAS PERMANENTLY DISCONTINUED AND THE PATIENT HAD A SHUNT SURGICALLY PLACED FOR HEMODIALYSIS. ON AN UNKNOWN DATE WHILE HOSPITALIZED, THE PATIENT BEGAN HEMODIALYSIS. AT THE TIME OF THIS REPORT, THE NURSE DID NOT KNOW IF THE PATIENT REMAINED HOSPITALIZED OR IF SHE WAS DISCHARGED FROM THE HOSPITAL. OUTCOME OF THE EDEMA IN HER TORSO AND LEGS AND FOR THE PERITONEAL LEAK WAS UNKNOWN.

    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 70 YR Hospitalization| R (B)(4)DIANEAL LOW CAL, SINGLE BAG DEXTROSE 1.50%.