BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2219313 · Received August 22, 2011

    Report

    Report Number
    1423500-2011-11056
    Event Type
    Injury
    Date Received
    August 22, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 3, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. A 510K NUMBER WILL NOT BE PROVIDED IN THE MDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. SINCE THE LOT NUMBER IS UNKNOWN, NO BATCH REVIEW WILL BE PERFORMED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE WAS DETERMINED TO BE USE ERROR.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A PATIENT WITH SUPPLEMENTAL INFORMATION PROVIDED BY A PHYSICIAN FROM (B)(6) OF PERITONITIS DUE TO A BREAK IN ASEPTIC TECHNIQUE. INITIALLY ON AN UNREPORTED DATE, THE PATIENT CALLED BAXTER (B)(4) TECHNICAL SERVICE CENTER REGARDING A LOW DRAIN VOLUME ALARM DURING THE INITIAL DRAINING CYCLE OF HIS HOMECHOICE DEVICE. DURING THE CONVERSATION THE PATIENT REPORTED THAT HE HAD BEEN HOSPITALIZED FOR PERITONITIS. THE INITIAL DATE OF HOSPITALIZATION WAS NOT REPORTED, HOWEVER, THE PATIENT REPORTED HE WAS DISCHARGED ON (B)(6) 2011. ON (B)(6) 2011 SUPPLEMENTAL INFORMATION WAS PROVIDED BY THE PATIENT'S PHYSICIAN. THE PERITONITIS CASE WAS MEDICALLY CONFIRMED AND WAS COINCIDENT WITH DIANEAL-N PD-4 1.5. THE PATIENT WAS IN HIS (B)(6) AT THE TIME OF THE EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL-N PD-4 1.5 SYSTEM II SINGLE BAG (5L, IP, FREQUENCY AND LOT # NOT REPORTED) THERAPY FOR CHRONIC RENAL FAILURE. THE PATIENT WAS TREATED WITH AN UNSPECIFIED ANTIBIOTIC. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE EVENT . THE REPORTING PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD-4 1.5 THERAPY, BUT RATHER DUE TO A BREAK IN ASEPTIC TECHNIQUE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL-N PD-4 1.5| HOMECHOICE