BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2228370 · Received August 31, 2011

    Report

    Report Number
    1423500-2011-11451
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    July 1, 2011
    Report Date
    August 11, 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 IS UNDETERMINED.

    Description of Event or Problem · 1

    THIS IS A REPORT BY A CUSTOMER FROM (B)(6) WITH SUPPLEMENTAL INFORMATION FROM A PHYSICIAN OF PERITONITIS AND POSSIBLE BREAK IN ASEPTIC TECHNIQUE. ON (B)(6) 2011, THE EMPLOYEE CALLED BAXTER (B)(6) TECHNICAL SERVICE CENTER FOR A HOMECHOICE SWAP AND REPORTED THAT THE PATIENT HAD PERITONITIS. TREATMENT, EVENT DETAILS, ACTION TAKEN WITH DIANEAL AND OUTCOME WERE NOT REPORTED. THE PHYSICIAN REPORTED , ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL-N PD-2 1.5 (2L, IP, FREQUENCY AND LOT # NOT REPORTED) AND EXTRANEAL (2L, IP, FREQUENCY AND LOT # NOT REPORTED) PERITONEAL DIALYSIS (PD) THERAPY FOR CHRONIC RENAL FAILURE. IN (B)(6) 2011, ABOUT 2 WEEKS PRIOR TO THIS REPORT, THE PATIENT EXPERIENCED AND WAS HOSPITALIZED FOR PERITONITIS. TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2011, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. DIANEAL-N PD-2 1.5 AND EXTRANEAL THERAPIES WERE ONGOING WITH DOSES UNCHANGED. THE PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD-2 1.5 OR EXTRANEAL THERAPY, BUT RATHER DUE TO A POSSIBLE BREAK IN ASEPTIC TECHNIQUE. CONCOMITANT MEDICATIONS WERE NOT REPORTED. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION.

    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 DIANEAL-N PD-2 1.5| EXTRANEAL