BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1740972 · Received June 29, 2010

    Report

    Report Number
    1423500-2010-01350
    Event Type
    Injury
    Date Received
    June 29, 2010
    Date of Event
    June 7, 2010
    Report Date
    June 7, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE FOR EVALUATION AS IT WAS DISCARDED.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CHECK SUPPLY LINE ALARM THAT OCCURRED WHILE REFILLING THE HEATER BAG IN THE FILL STATE. THE HOME PATIENT (HP) HAD FILLED WITH 1734MILLILITERS (ML). THE TECHNICAL SERVICE REPRESENTATIVE (TSR) ASSISTED THE HP'S HUSBAND TO END THERAPY EARLY AS THE HUSBAND HAD DISCONNECTED THE FINAL BAG AND MOVED IT TO THE HEATER LINE. THE HP WILL CARRY THE VOLUME GIVEN FOR THE DAY. THE HOMECHOICE WAS OPERATIONAL. THE HP'S NURSE CONTACTED BAXTER ON (B)(4) 2010 TO FOLLOW-UP ON THE CHECK SUPPLY LINE ALARM REPORT AND INDICATED THE PATIENT DEVELOPED PERITONITIS AFTER THIS EVENT. THE NURSE INDICATED SHE WAS INTERESTED BECAUSE THE HP NOW HAS PERITONITIS. THE TSR LOOKED UP THE CHECK SUPPLY LINE ALARM CALL AND INDICATED TO THE NURSE THAT THE HP WAS GETTING THE ALARM WHILE REFILLING THE HEATER AT THE TIME OF THE CALL. ALL THE SOLUTION BAGS WERE EMPTY EXCEPT THE FINAL BAG. THE TSR INDICATED THAT IT LOOKED LIKE THE CALLER HAD TRANSFERRED THE FINAL BAG TO THE HEATER LINE BUT THE HC ALARMED. THE TSR THEN HAD THE HP END THE THERAPY. THE RN UNDERSTOOD. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PATIENT'S PERITONEAL DIALYSIS (PD) NURSE ON (B)(4) 2010: THE PATIENT HAS A PAST MEDICAL HISTORY OF END STAGE RENAL DISEASE, DIABETES, AND HEART DISEASE. THE PATIENT STARTED PERITONEAL DIALYSIS THERAPY IN SEPTEMBER 2009, AND IS ON CONTINUOUS CYCLING PERITONEAL DIALYSIS (CCPD) THERAPY, USING LOCAL (PD4) AMBUFLEX. THE PATIENT'S PERITONEAL EFFLUENT WAS ANALYZED ON (B)(6) 2010 AND THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS ON (B)(6) 2010 AFTER THE DISCONNECTION THAT OCCURRED ON (B)(6) 2010. THE PATIENT WAS HOSPITALIZED ON (B)(6) 2010. THE CELL COUNT PERFORMED SHOWED A LEUKOCYTE COUNT OF 3770, A NEUTROPHIL COUNT OF 97, A LYMPHOCYTE COUNT OF 3, AND A MONOCYTE COUNT OF 1. A GRAM STAIN AND CULTURE WAS ALSO PERFORMED SHOWING GRAM NEGATIVE RESULTS, WITH MANY NEUTROPHILS AND A SCANT GROWTH OF KLEBSIELLA OXYTOCA. THE PATIENT WAS TREATED AT THE HOSPITAL INITIALLY WITH 3 GRAMS (G) OF ANCEF AND 2G OF FORTAZ INTRAVENOUSLY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010 AND CONTINUED TO RECEIVE 1.5G OF FORTAZ INTRAPERITONEAL. THE PERITONITIS IS CONSIDERED TO BE RESOLVED. NO FURTHER INFORMATION IS AVAILABLE.

    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 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R LOCAL (PD4) AMBUFLEX