BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2013907 · Received March 10, 2011

    Report

    Report Number
    1423500-2011-03026
    Event Type
    Injury
    Date Received
    March 10, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 20, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): THIS IS REPORT 4 OF 4 FOR THIS INCIDENCE 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 REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOTS (H10D30064, H10F01037, H10G30067, H10E04033, H10F17025, H10I14083, H10K05047, H10G26107) WAS PERFORMED WITH NO ISSUES NOTED DURING THE MANUFACTURING PROCESS. THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. THE ROOT CAUSE WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    ON (B)(6) 2011 THE CAREGIVER CONTACTED BAXTER REGARDING AN UNRELATED ALARM AND REPORTED THAT THE PATIENT HAD PERITONITIS. ON (B)(6) 2011, BAXTER CONTACTED THE PERITONEAL DIALYSIS (PD) RN FOR INFORMATION REGARDING THIS PERITONITIS. SHE REPORTED THE PATIENT WAS DIAGNOSED WITH PERITONITIS ON (B)(6) 2011. ON AN UNKNOWN DATE PD CULTURES WERE DONE. ON AN UNKNOWN DATE THE PATIENT BEGAN TREATMENT WITH ANCEF 1000MG DAILY FOR 21 DAYS. THE PATIENT COMPLETED TREATMENT ON AN UNKNOWN DATE AND HAS FULLY RECOVERED FROM THIS INCIDENCE OF PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THE NURSE REPORTED THAT THIS PERITONITIS WAS NOT RELATED TO ANY BAXTER SOLUTION OR DEVICE. SHE HAD NO OPINION OF CAUSALITY FOR THIS INCIDENCE OF PERITONITIS. THE PATIENT CONTINUED ON PD THERAPY. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Congenital Anomaly HOME CHOICE CYCLER| LOCAL PD4 AMBUFLEX| LOCAL PD4 ULTRABAG