BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2031979 · Received March 28, 2011

    Report

    Report Number
    1423500-2011-03755
    Event Type
    Injury
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 4, 2011
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE PRODUCT CODE AND LOT NUMBER OF THIS PRODUCT ARE UNKNOWN AT THIS TIME; THEREFORE THE 510K NUMBER WILL NOT BE PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS REPORT 2 OF 4 INVOLVED IN THIS PERITONITIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS PERFORMED FOR POTENTIALLY ASSOCIATED LOT NUMBERS H10F01037, H10G30067, H10H31055, AND H10G26024 WITH NO DEFECTS NOTED. THE ROOT CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A NURSE FROM (B)(6) IN WHICH THE PATIENT EXPERIENCED PERITONITIS AND STATED IT WAS "CAUSED BY BOWEL" (GASTROINTESTINAL DISORDER) COINCIDENT WITH DIANEAL PD4 AMBUFLEX THERAPY. ON AN UNREPORTED DATE, 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 PATIENT'S NURSE REPORTED THE FOLLOWING. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED THAT SAME DAY. THE PATIENT STATED THE PERITONITIS WAS CAUSED BY "BOWEL". IT WAS UNKNOWN IF A PERITONEAL EFFLUENT CULTURE WAS PERFORMED. ON AN UNREPORTED DATE IN 2011, DIANEAL THERAPY WAS WITHDRAWN. TREATMENT WAS NOT REPORTED AND THE PATIENT WAS RECOVERING FROM THE EVENT OF PERITONITIS. THE PD RN DECLINED FURTHER FOLLOW-UP. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    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 66 YR Hospitalization DIANEAL PD4 AMBUFLEX