BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP TRANSFER SET

    MDR report key: 2002417 · Received February 28, 2011

    Report

    Report Number
    1423500-2011-02507
    Event Type
    Injury
    Date Received
    February 28, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 10, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A REVIEW OF ALL BATCH RECORD DOCUMENTS FOR POTENTIALLY ASSOCIATED LOT (H10G30067) 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.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 5 OF 5 FOR THIS INCIDENCE OF PERITONITIS. AS PATIENT DISCARDS SUPPLIES AFTER EACH USE A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. FOLLOW UP INFORMATION WILL BE SENT AS IT BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT CALLED THE BAXTER TECHNICAL SERVICE REPRESENTATIVE FOR AN UNRELATED ALARM AND REPORTED THAT SHE HAD PERITONITIS. ON (B)(4) 2011, THE PERITONEAL DIALYSIS RN WAS CONTACTED. THE PDRN STATED THAT SHE WAS AWARE THAT THE PATIENT HAD PERITONITIS. SHE REPORTED THAT THE PATIENT PRESENTED WITH CLOUDY PERITONEAL DIALYSIS (PD) EFFLUENT ON (B)(6) 2011. PD CULTURES WERE TAKEN AT THAT TIME AND THE PATIENT WAS STARTED ON FORTAZ AND CEFAZOLIN. ON AN UNKNOWN DATE THE PD CULTURE AND GRAM STAIN WERE POSITIVE FOR STAPH AUREUS AND GRAM POSITIVE COCCI. ON AN UNKNOWN DATE THE PATIENT WAS SWITCHED TO LEVAQUIN FOR TREATMENT OF THE PERITONITIS. PD CELL COUNTS WERE TAKEN, BUT THE RESULTS WERE NOT AVAILABLE. THE PD RN REPORTED THAT ON (B)(6) 2011 THE PD CULTURES WERE RE-TAKEN AND THERE WERE NO ORGANISMS PRESENT. THE PATIENT HAS RECOVERED FROM THIS EPISODE OF PERITONITIS AND CONTINUES PD THERAPY WITHOUT DIFFICULTY. NO FURTHER INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention REGULAR CAL (PD2) AMBULFEX 2.5%| HOME CHOICE CYCLER