BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2226639 · Received August 30, 2011

    Report

    Report Number
    1423500-2011-11400
    Event Type
    Injury
    Date Received
    August 30, 2011
    Date of Event
    August 1, 2011
    Report Date
    August 10, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS. THE ROOT CAUSE OF THE REPORTED CONDITION OF PERITONITIS IS UNDETERMINED.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV). THIS IS A SPONTANEOUS REPORT BY A CONSUMER WITH SUPPLEMENTAL INFORMATION BY THE PHYSICIAN IN (B)(6) OF PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX , DIANEAL-N PD-4 1.5 AND DIANEAL-N PD-4 2.5 THERAPIES. ON (B)(6) 2011, THE PATIENT EXPERIENCED PERITONITIS AND WAS HOSPITALIZED ON THE SAME DATE. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. THE PATIENT RECEIVED REMEDIAL THERAPY WITH CEFAMEZIN (DOSE, FREQUENCY AND ROUTE NOT REPORTED) FOR THE EVENT OF PERITONITIS. ON (B)(6) 2011 THE EVENT OF PERITONITIS RESOLVED. THERE WAS NO PROBLEM WITH ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING AT UNCHANGED DOSE. ACTION TAKEN WITH EXTRANEAL VIAFLEX , DIANEAL-N PD-4 1.5 AND DIANEAL-N PD-4 2.5 THERAPIES WAS NOT REPORTED. THE PHYSICIAN ASSESSED THE CAUSALITY AS UNKNOWN, BECAUSE THERE WAS NO INFORMATION TO DENY THE CAUSALITY. THE PATIENT HAD OFTEN DEVELOPED ENTEROCOLITIS BEFORE PD THERAPY WAS BEGUN. THE PHYSICIAN COULD NOT RULE OUT THE POSSIBILITY THAT ENTEROCOLITIS HAD CAUSED THE EVENT OF PERITONITIS. THE PATIENT'S CONCOMITANT MEDICATIONS WERE NOT REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL VIAFLEX| DIANEAL| DIANEAL-N PD-4 1.5