BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2241980 · Received September 9, 2011

    Report

    Report Number
    1423500-2011-12011
    Event Type
    Injury
    Date Received
    September 9, 2011
    Date of Event
    August 20, 2011
    Report Date
    August 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). 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

    ON (B)(6) 2011, A BAXTER (B)(6) TECHNICAL SERVICE CENTER REPRESENTATIVE CALLED THE PATIENT'S HOME REGARDING A REGULAR CHECK OF THE DIALYSIS DEVICE. A CONSUMER ANSWERED THE PHONE AND REPORTED THAT THE PATIENT HAD BEEN HOSPITALIZED FOR PERITONITIS SINCE (B)(6) 2011. FOLLOW-UP WITH THE PHYSICIAN REVEALED THE FOLLOWING INFORMATION: ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WHICH REQUIRED HOSPITALIZATION ON THE SAME DATE. MODACIN (CEFTAZIDIME HYDRATE; 1G, ROUTE NOT REPORTED, ALTERNATE DAY) AND VANCOMYCIN (VANCOMYCIN HYDROCHLORIDE; 0.5G, ROUTE NOT REPORTED, ALTERNATE DAY) THERAPIES WERE RENDERED. ON AN UNREPORTED DATE, THE PATIENT WAS RECOVERING FROM THE EVENT. DIANEAL-N PD-4 1.5 AND EXTRANEAL THERAPIES WERE ONGOING WITH DOSE UNCHANGED. THE PHYSICIAN STATED THAT THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL-N PD-4 1.5 AND EXTRANEAL.

    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 73 YR Hospitalization| R DIANEAL-N PD-4 1.5| EXTRANEAL