BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1980853 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01606
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 2011
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 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 AND WILL CONTINUE TO MONITOR THESE REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    THIS IS A REGULATORY REPORT FROM (B)(4) OF ASEPTIC PERITONITIS IN A (B)(6) FEMALE PATIENT SUBSEQUENT TO EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN BAG AND PHYSIONEAL THERAPIES. THIS REPORT WAS RECEIVED BY THE FRENCH HEALTH AUTHORITIES AND FORWARDED TO BAXTER. FROM (B)(6) 2010, THE PATIENT WAS UNDER PERITONEAL DIALYSIS WITH PHYSIONEAL, ONE BAG IN THE MORNING, NUTRINEAL PD4 UNKNOWN BAG AT NOON, PHYSIONEAL ONE BAG IN THE AFTERNOON AND EXTRANEAL VIAFLEX ONE BAG IN THE EVENING WITH LONG DWELL UNTIL THE FOLLOWING MORNING INTRAPERITONEALLY (IP) FOR PERITONEAL DIALYSIS (PD). ON (B)(6) 2011, THE PATIENT EXPERIENCED ASEPTIC PERITONITIS WITH NO SYMPTOMS AFTER RECEIVING EXTRANEAL VIAFLEX. THE DAY BEFORE, THE PATIENT HAD RECEIVED NUTRINEAL PD4 UNKNOWN BAG. IT WAS NOT REPORTED WHETHER PERITONEAL EFFLUENT ANALYSIS WAS PERFORMED, OR IF THE PATIENT RECEIVED REMEDIAL TREATMENT. THE OUTCOME WAS REPORTED AS FAVORABLE, AND THE PATIENT RECOVERED ON AN UNREPORTED DATE IN (B)(6) 2011. ACTION TAKEN WITH EXTRANEAL VIAFLEX, NUTRINEAL PD4 UNKNOWN BAG AND PHYSIONEAL WERE NOT REPORTED. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. (B)(4) HEALTH AUTHORITIES CONSIDERED EXTRANEAL AND NUTRINEAL AS SUSPECT DRUGS AND CAUSAL RELATIONSHIP WAS RATED, ACCORDING TO THE (B)(4) METHODOLOGY OF CAUSALITY ASSESSMENT, AS POSSIBLE FOR BOTH. BAXTER CONSIDERED PHYSIONEAL A SUSPECT PRODUCT (REPORTED AS CONCOMITANT DRUG).

    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 77 YR Required Intervention PHYSIONEAL| EXTRANEAL| NUTRINEAL