BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1893803 · Received November 9, 2010

    Report

    Report Number
    1423500-2010-05489
    Event Type
    Injury
    Date Received
    November 9, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 18, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    NURSE

    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 510(K) 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. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTION IS REQUIRED. THIS IS THREE OF FOUR CASE REPORTS FROM THE SAME HOSPITAL INVOLVING FOUR MALE PATIENTS EXPERIENCING STERILE PERITONITIS DURING CONTINUOUS AMBULATORY PERITONEAL DIALYSIS THERAPY.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF STERILE PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE HOSPITAL NURSE REPORTED THAT THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE IN 2010, THE PATIENT WAS TREATED WITH GLAZIDIM AND TOTACEF FOR 15 DAYS (DOSE, FREQUENCY AND ROUTE NOT REPORTED). ACCORDING TO THE NURSE, THE PATIENT IS CURRENTLY IN GOOD HEALTH CONDITIONS. DIANEAL THERAPY CONTINUED, WITH DOSE UNCHANGED. THE NURSE DID NOT PROVIDE AN OPINION OF CAUSALITY FOR THE EVENT OF STERILE PERITONITIS.

    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 Required Intervention