BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2933902 · Received January 29, 2013

    Report

    Report Number
    1416980-2013-02218
    Event Type
    Injury
    Date Received
    January 29, 2013
    Date of Event
    January 1, 2013
    Report Date
    January 11, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN; THEREFORE, MANUFACTURER SITE IS 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 CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE PROBLEM WAS NOT CONFIRMED AND THE CAUSE OF THE PERITONITIS WAS UNDETERMINED. NO DEVICE MALFUNCTION OR USE ERROR WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    (B)(4). FURTHER INFORMATION WAS RECEIVED FROM A NURSE, WHICH MEDICALLY CONFIRMED THE CASE. ON AN UNREPORTED DATE, THE PATIENT WAS STARTED ON UNSPECIFIED ANTIBIOTICS UNTIL (B)(6) 2013 FOR PERITONITIS. ON AN UNREPORTED DATE, 5 DAYS AFTER HOSPITALIZATION, THE PATIENT WAS DISCHARGED. THE PATIENT RECOVERED FROM THIS PERITONITIS EVENT.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A CONSUMER FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH DIANEAL AND EXTRANEAL THERAPIES FOR PERITONEAL DIALYSIS (PD). ACTION TAKEN WITH DIANEAL AND EXTRANEAL THERAPIES WAS UNKNOWN. ON (B)(6) 2013, THE CONSUMER CONTACTED BAXTER CUSTOMER CARE REPRESENTATIVE AND THE FOLLOWING WAS REPORTED. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED FOR FIVE DAYS DUE TO THE EVENT. THE CAUSE OF PERITONITIS AND TREATMENT WAS NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT WAS DISCHARGED. THE OUTCOME OF THIS PERITONITIS EVENT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39561 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL| DIANEAL PD4 2.5%| DIANEAL PD4 1.5%