BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1982328 · Received February 9, 2011

    Report

    Report Number
    1423500-2011-01684
    Event Type
    Injury
    Date Received
    February 9, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 22, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS IS REPORT 1 0F 3 FOR THIS INCIDENT OF PERITONITIS. AS PATIENTS DISCARD SUPPLIES AFTER EACH USE, A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP WILL BE SUBMITTED AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10K15053, H10J17028 WITH NO DEFECTS NOTED. THE ASSIGNABLE CAUSE IS USE ERROR-POOR AESEPTIC TECHNIQUE. THE CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO THE PREVENTION OF USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED CONDITION. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, DURING A FOLLOW UP CALL FOR AN UNRELATED ALARM, THE PATIENT'S CAREGIVER REPORTED THE HOME PATIENT WAS ON ANTIBIOTICS FOR A CURRENT PERITONITIS. NO FURTHER INFORMATION WAS AVAILABLE AT THE TIME. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) TO GET FURTHER INFORMATION ABOUT THIS EPISODE OF PERITONITIS. THE PDRN STATED THAT THE PATIENT HAS PERITONITIS AND IS BEING TREATED. THE PATIENT HAS CONTINUED PERITONEAL DIALYSIS(PD) THERAPY WITHOUT DIFFICULTY. ON (B)(6) 2011, THE PATIENT BEGAN TREATMENT WITH CEPHAZOLIN (UNKNOWN DOSE ) FOR 21 DAYS. ANTIBIOTIC THERAPY IS ONGOING. THE PATIENT'S CONDITION HAS IMPROVED. THE NURSE REPORTED THAT THE CAUSE OF THIS PERITONITIS WAS A BREAK IN ASEPTIC TECHNIQUE. THE PATIENT IS BEING RETRAINED. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY PRODUCTCODE FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention HOME CHOICE CYCLER| ULTRA BAG DEXTROSE 1.50%..| DIANEAL LOW CAL