BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2173042 · Received July 23, 2011

    Report

    Report Number
    1423500-2011-09315
    Event Type
    Injury
    Date Received
    July 23, 2011
    Date of Event
    June 1, 2011
    Report Date
    June 20, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A BATCH REVIEW WAS NOT PERFORMED AS THE LOT NUMBER WAS UNKNOWN. THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    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.

    Description of Event or Problem · 1

    THE (B)(6) CALL CENTER RECEIVED A REPORT THE PATIENT WAS HOSPITALIZED DUE TO PERITONITIS. THE PATIENT USED THE UV TRANSFER-SET, UV YUME-SET, HOMECHOICE PLUS, AND CLEAN FLASH. THIS IS A SPONTANEOUS CONSUMER REPORT FROM (B)(6) OF PERITONITIS IN A FEMALE PATIENT COINCIDENT WITH DIANEAL UNKNOWN THERAPY. ON AN UNKNOWN DATE, SHE BEGAN DIANEAL UNKNOWN THERAPY. ON (B)(6) 2011, SHE CONTACTED BAXTER (B)(6) TECHNICAL SERVICE CENTER AND STATED THAT SHE HAD BEEN HOSPITALIZED DUE TO PERITONITIS. FOLLOW-UP INFORMATION WAS MADE BY A PHYSICIAN ON (B)(6) 2011. THE PATIENT WAS IN HER 60'S. MEDICAL HISTORY INCLUDED HYPERTENSION AND SYSTEMIC LUPUS ERYTHEMATOSUS. IN (B)(6) 2007, SHE BEGAN DIANEAL-N PD-4 1.5%, 2.5% AND EXTRANEAL THERAPIES. A COURSE OF ANTIBIOTICS INCLUDING CEFAMEZIN WAS PRESCRIBED FOR THE EVENT. THE EVENT WAS RESOLVING AND PD THERAPY WAS CONTINUED UNCHANGED. THE PHYSICIAN BELIEVED THAT THE EVENT WAS NOT RELATED TO PD THERAPY. THE EVENT WAS CAUSED BY TOUCH CONTAMINATION. THE PERITONITIS WAS UNRELATED TO THE BAXTER SOLUTIONS OR PRODUCTS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R DIANEAL-N PD-4 2.5%| EXTRANEAL| HOMECHOICE| DIANEAL-N PD-4 1.5%,