BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AUTOMATED PD SET W/CASSETTE4 PRONG

    MDR report key: 1896800 · Received November 11, 2010

    Report

    Report Number
    1423500-2010-05601
    Event Type
    Injury
    Date Received
    November 11, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOTS ((H10G13022 AND H10H27053) WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THE ROOT CAUSE WAS NOT DETERMINED. 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. THIS IS REPORT 1 OF 2 FOR THIS EVENT.

    Description of Event or Problem · 1

    DURING A FOLLOW-UP CALL FOR THE PATIENT'S BACTERIAL PERITONITIS EPISODE ON (B)(6) 2010, THE NURSE INDICATED THAT THE PATIENT STARTED ON AUTOMATED PERITONEAL DIALYSIS (APD) WITH LOCAL(PD4) AMBUFLEX IN 2009. THE NURSE ALSO INDICATED THE PATIENT WAS DIAGNOSED WITH A FUNGAL PERITONITIS EPISODE ON (B)(6) 2010 AND WAS HOSPITALIZED FOR THE PERITONITIS. THE NURSE INDICATED THE CAUSE OF THAT PERITONITIS IS UNKNOWN AND THAT THE PATIENT'S CATHETER IS GOING TO BE REMOVED. THE NURSE INDICATED SHE DID NOT HAVE ANY EFFLUENT ANALYSIS RESULTS FOR THIS NEW PERITONITIS EPISODE YET.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS OBTAINED FROM THE PATIENT'S NURSE: THE NURSE INDICATED THAT AS THE PATIENT WAS TREATED IN THE HOSPITAL, SHE DOES NOT HAVE ANY ADDITIONAL INFORMATION TO PROVIDE. THE NURSE DID INDICATE THAT THE PATIENT'S CATHETER WAS PULLED AND THE PATIENT IS NOW ON HEMODIALYSIS AND IS DOING WELL. 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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R LOCAL (PD4) AMBUFLEX