BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1962057 · Received January 17, 2011

    Report

    Report Number
    1423500-2011-00695
    Event Type
    Injury
    Date Received
    January 17, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 30, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS (H10H21023, H10H11099, AND H10I10107), WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR- POOR ASEPTIC TECHNIQUE. CURRENT LABELING PROVIDES AMPLE INSTRUCTIONS RELATED TO PREVENTION OF THE SUSPECTED USE ERROR IN ASEPTIC TECHNIQUE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN THE SAMPLE WAS NOT REQUESTED.

    Description of Event or Problem · 1

    DURING FOLLOW-UP ON AN UNRELATED ALARM, THE PATIENT INDICATED SHE WAS ON ANTIBIOTICS FOR PERITONITIS. THE PATIENT STATED THAT THE PERITONITIS IS NOT RELATED TO THE PERITONEAL DIALYSIS (PD) THERAPY OR BAXTER PRODUCTS. THE PATIENT STATED THAT SHE WAS DIAGNOSED WITH PERITONITIS ABOUT 2 WEEKS AGO (B)(6) AND THAT SHE CONTINUING THERAPY. DURING FOLLOW-UP ON (B)(6) 2011 WITH THE PATIENT'S PD NURSE, THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED: THE PATIENT BEGAN ON PD THERAPY WITH LOCAL (PD4) AMBUFLEX ON (B)(6) 2010. ON (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH BACTERIAL PERITONITIS AND WAS HOSPITALIZED. THERE WAS NO EXIT SITE OR TUNNEL INFECTION ASSOCIATED WITH THIS PERITONITIS. THE PATIENT'S EFFLUENT WAS ANALYZED ON (B)(6) 2010; HOWEVER, THE CELL COUNT AND GRAM STAIN RESULTS ARE UNKNOWN AS THEY WERE TAKEN IN THE HOSPITAL. THE NURSE DID INDICATE THAT THE CULTURE RESULTS SHOWED COAGULASE (B)(6). THE PATIENT'S NURSE INDICATED THAT THE PATIENT'S TRANSFER SET WAS NOT REPLACED AFTER THE PERITONITIS WAS DIAGNOSED. THE PATIENT WAS TREATED WITH ANTIBIOTICS AND HAS RECOVERED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2010. THE NURSE INDICATED THE CAUSE OF THE PERITONITIS WAS NOT ANY HOMECHOICE ALARM BUT WAS LIKELY A BREAK IN THE PATIENT'S ASEPTIC TECHNIQUE. THE PATIENT HAS BEEN ABLE TO CONTINUE WITH PERITONEAL DIALYSIS (PD) THERAPY WITHOUT FURTHER ISSUES. NO ALLEGATIONS WERE MADE AGAINST ANY OF THE PATIENT'S DIALYSIS PRODUCTS. NO FURTHER INFORMATION IS EXPECTED.

    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 53 YR Hospitalization| R LOCAL (PD4) AMBUFLEX