BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1911236 · Received December 1, 2010

    Report

    Report Number
    1423500-2010-06401
    Event Type
    Injury
    Date Received
    December 1, 2010
    Date of Event
    November 1, 2010
    Report Date
    November 7, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    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, A BATCH REVIEW AND LABELING REVIEW WILL NOT 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A BAXTER EMPLOYED HEALTHCARE PROFESSIONAL FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT DEVELOPED PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED FOR THE EVENT. ON (B)(6) 2010, THE PATIENT WAS TREATED WITH CEFAZOLIN 1 GRAM IP ONCE DAILY (CONTINUING) AND CEFTAZIDIME 1 GRAM IP ONCE DAILY (CONTINUING). THE EVENT OF PERITONITIS WAS RESOLVING. DIANEAL THERAPY WAS ONGOING. THE NURSE STATED THE EVENT OF PERITONITIS WAS UNRELATED TO DIANEAL. THE ROOT CAUSE OF THE PERITONITIS WAS UNKNOWN.

    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 15 YR Required Intervention DIANEAL PD2 ULTRABAG