BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1880636 · Received October 25, 2010

    Report

    Report Number
    1423500-2010-04863
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    October 1, 2010
    Report Date
    October 4, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    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 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 RECEIVED SIMILAR REPORTS FOR THE REPORTED PROBLEM.

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INCIDENT OF PERITONITIS WAS REPORTED WITH THE USE OF NUTRINEAL. THE NUTRINEAL HAS BEEN IDENTIFIED AS THE CAUSE OF THIS PERITONITIS. THE NUTRINEAL LOT NUMBER INVOLVED IN THIS INCIDENT (10G12G44) IS ONLY DISTRIBUTED IN EUROPE AND HAS BEEN WITHDRAWN FROM THE MARKET DUE TO COMPLAINTS OF STERILE PERITONITIS. (B)(4).

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A PHYSICIAN FROM (B)(6) OF PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND SLIGHT ABDOMINAL PAIN WITHOUT OTHER ILLNESS SYMPTOMS. THE PATIENT WAS DIAGNOSED WITH PERITONITIS. REMEDIAL TREATMENT WAS INITIATED FOLLOWING GENERAL PERITONITIS TREATMENT PROTOCOL. ON (B)(6) 2010, THE ABDOMINAL PAIN AGGRAVATED BUT BESIDES THIS, THE PATIENT WAS NOT SICK. HE HAD A LOT OF CLOUDY EFFLUENT, ESPECIALLY FROM THE NUTRINEAL BAGS. ON (B)(6) 2010, NUTRINEAL AND ANTIBIOTICS WERE STOPPED. THE PATIENT CONTINUED TO USE PHYSIONEAL 1.36% (2L, 4X/DAY) AND HAD NO COMPLAINTS. NUTRINEAL WAS NOT REINTRODUCED. PER THE REPORTER, THE EVENT WAS RELATED TO NUTRINEAL OR AT LEAST TO THE NUTRINEAL LOT NUMBER IN USE AT THAT TIME (LOT NUMBER NOT SPECIFIED). THE REPORTER DID NOT SPECIFICALLY COMMENT ON THE RELATIONSHIP BETWEEN THE EVENT AND PHYSIONEAL.

    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 56 YR Required Intervention