BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1974505 · Received January 31, 2011

    Report

    Report Number
    1423500-2011-01317
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    July 1, 2010
    Report Date
    July 1, 2010
    Manufacturer
    BAXTER HEALTHCARE CORPORATION - RENAL DIVISION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    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. FOLLOW UP INFORMATION WILL BE SUBMITTED AS IT BECOMES AVAILABLE. .

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS CONSUMER REPORT FROM (B)(6) OF PUNCTURED DRAIN BAG AND PERITONITIS IN A MALE PATIENT, COINCIDENT WITH DIANEAL PD2 UNKNOWN BAG THERAPY. ON AN UNREPORTED DATE, THE PATIENT BEGAN DIANEAL PD2 UNKNOWN BAG THERAPY (IP), FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2010, THE PATIENT CALLED BAXTER CUSTOMER SERVICE TO REPORT A PUNCTURED DRAIN BAG. HE ALSO REPORTED THAT , ON AN UNREPORTED DATE, THE PATIENT DEVELOPED PERITONITIS. LAB TESTS, TREATMENT, AND OUTCOME WERE NOT REPORTED. IT WAS UNKNOWN WHETHER DIANEAL PD2 UNKNOWN BAG THERAPY WAS ONGOING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other