BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1963835 · Received January 19, 2011

    Report

    Report Number
    1423500-2011-00762
    Event Type
    Injury
    Date Received
    January 19, 2011
    Date of Event
    November 1, 2010
    Report Date
    December 30, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICES INVOLVED IN THE INCIDENT WERE UNKNOWN. A BATCH REVIEW WILL NOT BE PERFORMED AS THE LOT NUMBER 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 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR AS THE PRODUCT CODE AND LOT NUMBER ARE UNKNOWN. BAXTER HAS RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THIS IS A SOLICITED REPORT BY A NURSE FROM (B)(6) OF BACTERIAL PERITONITIS SUBSEQUENT TO RECEIVING DIANEAL PD4 UNKNOWN BAG THERAPY INTRAPERITONEALLY (IP) DURING PERITONEAL DIALYSIS (PD). ON (B)(6) 2007, THE PATIENT BEGAN TREATMENT WITH DIANEAL PD4 UNKNOWN BAG THERAPY (DOSE AND FREQUENCY NOT REPORTED). DIANEAL PD4 UNKNOWN BAG THERAPY WAS ONGOING. IT WAS UNKNOWN WHETHER THE EVENT RESOLVED. THE REPORTER DID NOT PROVIDE AN OPINION OF CAUSALITY.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other DIANEAL PD4 UNK BAG| OMEPRAZOLE, ALFACALCIDOL, RENAGEL, FUROSEMIDE| SIMVASTATIN, DIHYDROCODEINE, PARACETAMOL, TRAMADOL| NABUMETONE, FUROSEMIDE, AMITRIPTYLINE