BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2345925 · Received November 22, 2011

    Report

    Report Number
    1423500-2011-15479
    Event Type
    Injury
    Date Received
    November 22, 2011
    Date of Event
    October 1, 2011
    Report Date
    November 4, 2011
    Manufacturer
    BAXTER HEALTCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM (B)(6) AND IS A SPONTANEOUS CONSUMER REPORT WITH SUPPLEMENTAL INFORMATION BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL -N PD-4 1.5 AND DIANEAL - N PD- 4 2.5 THERAPIES. DURING A CALL TO BAXTER (B)(4) TECHNICAL SERVICE, THE FOLLOWING WAS REPORTED. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS HOSPITALIZED DUE TO THE EVENT. ON AN UNREPORTED DATE, TREATMENT INCLUDED ANTIBIOTIC THERAPY (NAME OF DRUG, DOSE, FREQUENCY, AND ROUTE NOT REPORTED). IT WAS NOT REPORTED IF ANTIBIOTIC THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE EVENT WAS RESOLVING. DIANEAL THERAPIES WERE ONGOING. THE PHYSICIAN REPORTED THAT THE PERITONITIS BACTERIAL WITH (B)(6) WAS UNRELATED TO DIANEAL THERAPY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL - N PD- 4 2.5| DIANEAL -N PD-4 1.5