BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2140252 · Received June 26, 2011

    Report

    Report Number
    1423500-2011-08372
    Event Type
    Injury
    Date Received
    June 26, 2011
    Date of Event
    May 1, 2011
    Report Date
    June 2, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    OTHER

    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 SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT (BORN IN (B)(6)) COINCIDENT WITH DIANEAL PD4 ULTRABAG THERAPY. ON (B)(6) 2007, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 ULTRABAG THERAPY (DOSE AND FREQUENCY NOT REPORTED, LOT NUMBERS UNKNOWN) INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS, MANIFESTED BY ABDOMINAL PAIN AN CLOUDY SOLUTION. ON (B)(6) 2011, THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. REMEDIAL TREATMENT INCLUDED CEFAZOLINE (1 G X 2 G/DAILY) AND GENTAMYCIN (40 MG X 80 MG/DAILY). ON (B)(6) 2011, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PERITONITIS WAS ONGOING AND IMPROVED. DIANEAL PD4 ULTRABAG THERAPY WAS ONGOING. THE PATIENT WAS NOT TAKING ANY CONCOMITANT MEDICATIONS. THE CONSUMER BELIEVED THE PERITONITIS WAS UNRELATED TO DIANEAL PD4 ULTRABAG THERAPY AND REPORTED THE CAUSE OF THE PERITONITIS AS A POOR ENVIRONMENT.

    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 PD4 ULTRABAG