BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAPD DISCONNECT Y SET

    MDR report key: 2132729 · Received June 17, 2011

    Report

    Report Number
    1423500-2011-07763
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 1, 2011
    Report Date
    May 25, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    PMA / PMN Number
    K961825
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS REPORT 3 OF 3 INVOLVED IN THIS PERITONITIS EVENT. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A FOLLOW-UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS WAS UNDETERMINED. A BATCH REVIEW WAS PERFORMED FOR THE POTENTIALLY ASSOCIATED LOT NUMBERS (H11A26034, H10L20028). THERE WERE NO DEVIATIONS FROM STANDARD PROCEDURE. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM (B)(6). THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY A NURSE FROM (B)(6) OF PERITONITIS COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE IN (B)(6) 2009, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 AMBUFLEX (LOT NUMBER, DOSE, AND FREQUENCY NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). DURING A CALL WITH BAXTER CUSTOMER SERVICES, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. ON AN UNREPORTED DATE IN (B)(6) 2011, A PERITONEAL EFFLUENT CULTURE WAS PERFORMED AND THE RESULTS WERE UNKNOWN. TREATMENT WAS NOT REPORTED AND AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING. PD THERAPY WAS ONGOING. MEDICAL HISTORY INCLUDED (B)(6), HYPERTENSION, AND STROKE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE STATED THE EVENT WAS NOT RELATED TO PD THERAPY. THE FOLLOWING ARE POTENTIALLY ASSOCIATED LOTS FOR THIS PERITONITIS EVENT: H11A26034, H10L20028.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other DIANEAL PD4 AMBUFLEX| HOMECHOICE