BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1972966 · Received January 28, 2011

    Report

    Report Number
    1423500-2011-01210
    Event Type
    Injury
    Date Received
    January 28, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 6, 2011
    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. AS THE DATE OF ONSET OF THIS PERITONITIS EPISODE IS UNKNOWN AND PATIENTS DISCARD SUPPLIES AFTER EACH THERAPY, THE SAMPLE WAS NOT REQUESTED. THE ROOT CAUSE FOR THIS INCIDENT IS UNDETERMINED AT THIS TIME. A 510(K) NUMBER WILL NOT BE PROVIDED IN THE EMDR 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.

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY A NURSE FROM (B)(6) OF PERITONITIS WITH CLOUDY BAGS IN A MALE PATIENT (AGE NOT REPORTED) COINCIDENT WITH DIANEAL UNKNOWN AND EXTRANEAL VIAFLEX THERAPIES. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH DIANEAL UNKNOWN AND EXTRANEAL VIAFLEX (DOSE, FREQUENCY, AND LOT NUMBERS NOT REPORTED) INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS WITH CLOUDY BAGS. ON (B)(6) 2011, THE PATIENT CONTACTED THE HOSPITAL TO REPORT THAT HE HAD "CLOUDY BAGS." ON THIS SAME DATE, HE WAS GIVEN "PROTOCOL ANTIBIOTICS" AS REMEDIAL MEDICATION TO TREAT HIS PERITONITIS. AT THE TIME OF REPORTING, THE PATIENT CONTINUED TO RECEIVE REMEDIAL TREATMENT WITH "PROTOCOL ANTIBIOTICS" AND HIS PERITONITIS WITH CLOUDY BAGS HAD NOT RESOLVED. DIANEAL AND EXTRANEAL THERAPIES CONTINUED. THE PATIENT'S MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE NURSE DID NOT PROVIDE AN ASSESSMENT 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 Required Intervention