BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP

    MDR report key: 1904935 · Received November 22, 2010

    Report

    Report Number
    1423500-2010-05983
    Event Type
    Injury
    Date Received
    November 22, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 26, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K882498
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENT'S DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 4 OF 4 INVOLVED IN THIS PERITONITIS EVENT. THE LOT NUMBER WAS NOT PROVIDED; THEREFORE, A BATCH REVIEW CANNOT BE CONDUCTED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM THE USA OF PERITONITIS WITH CULTURE POSITIVE FOR STAPHYLOCOCCUS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. DURING A CALL WITH BAXTER CUSTOMER SERVICE, THE PATIENT'S NURSE REPORTED THE FOLLOWING INFORMATION. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT AND IT WAS UNREPORTED IF TREATMENT WAS PROVIDED. IT WAS UNREPORTED IF PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT HAD RECOVERED FROM THE PERITONITIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MINICAP EXTEND LIFE PD TRANSFSET W/TWIST CLAMP SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Other DIANEAL PD4 AMBUFLEX AND EXTRANEAL VIAFLEX