BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2162412 · Received July 14, 2011

    Report

    Report Number
    1423500-2011-09032
    Event Type
    Injury
    Date Received
    July 14, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 19, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES PRODUCT CODES 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. SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THE HOME PATIENT (HP) CALLED BAXTER (B)(4) AND REPORTED THAT ON (B)(6) 2011 HE WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS AND HERNIA. THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. ON (B)(6) 2011, THE PHYSICIAN CONFIRMED THAT THE HP WAS ADMITTED TO THE HOSPITAL FOR PERITONITIS AND INGUINAL HERNIA. THE PHYSICIAN STATED THAT THE EVENTS WERE RESOLVING AT THE TIME OF THIS REPORT. PD THERAPY WAS ONGOING. PER THE PHYSICIAN, CAUSALITY WAS DUE TO A BREAK IN ASEPTIC TECHNIQUE AND WAS NOT RELATED TO THE PD THERAPY.

    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