BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2833640 · Received November 15, 2012

    Report

    Report Number
    1416980-2012-05234
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 24, 2012
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW UP INFORMATION WAS RECEIVED FROM A PHYSICIAN. ON (B)(6) 2012, THE PATIENT EXPERIENCED A PAIN AND CLOUDY EFFLUENT AND WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, AFTER 5 DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED. ON (B)(6) 2012, THE PATIENT EXPERIENCED A SUSPICION OF PERITONITIS. THE PATIENT WAS TREATED WITH GENTAMICIN AND VANCOMYCIN (DOSES, FREQUENCIES, LOT NUMBERS AND ROUTE OF ADMINISTRATION WERE NOT REPORTED). THE GENTAMICIN LEVEL WAS 4.7 AND THE VANCOMYCIN LEVEL WAS 19.6. ON AN UNREPORTED DATE, THE PATIENT RECOVERED.

    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 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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT BY A PHYSICIAN IN DENMARK OF SUSPICION OF PERITONITIS IN A PATIENT COINCIDENT WITH EXTRANEAL THERAPY FOR OVERHYDRATION. EXTRANEAL THERAPY WAS ONGOING. ON (B)(6) 2012, THE PATIENT EXPERIENCED A SUSPICION OF PERITONITIS AND WAS HOSPITALIZED. TREATMENT WAS NOT REPORTED. ON (B)(6) 2012, AFTER 5 DAYS OF HOSPITALIZATION, THE PATIENT WAS DISCHARGED. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THIS EVENT.

    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 46 YR Hospitalization APOVIT C-VITAMIN| RENAGEL| FOSRENOL| APOVIT B-COMBIN| ALLOPURINOL| LAMICTAL| TRAMADOL| ACTAVIS| PAMOL| UNIKALK| KALEORID| KALEORID PROLONGED RELEASE| OMEPRAZOLE ACTAVIS| EXTRANEAL| PREDNISOLONE OAK| NEORECORMON| PREDNISOLONE DAK