BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1880613 · Received October 22, 2010

    Report

    Report Number
    1423500-2010-04837
    Event Type
    Injury
    Date Received
    October 22, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 30, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 THE NUTRINEAL LOT NUMBER INVOLVED IN THIS INCIDENT (10G12G44) IS ONLY DISTRIBUTED IN EUROPE AND HAS BEEN WITHDRAWN FROM THE MARKET DUE TO COMPLAINTS OF STERILE PERITONITIS.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).

    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.

    Description of Event or Problem · 1

    Description of Event or Problem · 1

    THIS IS A SPONTANEOUS REPORT BY NEPHROLOGIST AND PHARMACIST FROM (B)(6) OF ASEPTIC PERITONITIS IN A PATIENT COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THIS IS 1 OF 2 REPORTS BY THE SAME REPORTER. ON (B)(6) 2010, AT THE END OF THE AFTERNOON, THE PATIENT EXPERIENCED CLOUDY EFFLUENT AND PAIN IN THE RIGHT HYPOCHONDRIUM. THE PAIN IN THE RIGHT HYPOCHONDRIUM WAS ASSESSED AS MODERATE. THE DIALYSATE WAS DRAINED AND THE PAIN IN THE RIGHT HYPOCHONDRIUM RESOLVED. THE PHYSICIAN DIAGNOSED THE PATIENT WITH ASEPTIC PERITONITIS. THE PATIENT WAS NOT HOSPITALIZED. THERE WAS NO BREAK IN ASEPTIC TECHNIQUE, NO EXIT SITE INFECTION, THE PATIENT WAS VERY COMPLIANT WITH HIS TREATMENT AND DIET, AND DID NOT ROUTINELY RE-USE SUPPLIES. THE PATIENT WAS NOT RETRAINED. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFACIDAL (CEFAZOLINE, 1 G) AND GENTALLINE (GENTAMYCINE, 100 MG) IP (FREQUENCIES NOT REPORTED) AND DURING THE REMEDIAL THERAPY THE DIALYSATE EFFLUENT WAS CLEAR. ON (B)(6) 2010, THE PATIENT EXPERIENCED CLOUDY EFFLUENT . ON (B)(6) 2010, REMEDIAL THERAPY WITH CEFACIDAL AND GENTALLINE WAS STOPPED. ON (B)(6) 2010, NUTRINEAL WAS STOPPED. ON (B)(6) 2010, THE PATIENT BEGAN REMEDIAL THERAPY WITH CEFACIDAL 1 G AND CEFTRIAXONE 1 G (ROUTES AND FREQUENCIES NOT REPORTED). ON (B)(6) 2010, REMEDIAL THERAPY WITH CEFACIDAL AND CEFTRIAXONE WAS STOPPED AND THE PATIENT WAS TREATED WITH ORAL BACTRIM (SULFAMETHOXAZOLE AND TRIMETHOPRIME). ON (B)(6) 2010, REMEDIAL THERAPY WITH BACTRIM WAS STOPPED. ON (B)(6) 2010, THE PATIENT RECEIVED REMEDIAL THERAPY WITH CEFTRIAXONE 1 G DAILY AND VANCOMYCINE 1 G DAILY (ROUTE NOT REPORTED). THE OUTCOME OF THE ASEPTIC PERITONITIS WAS UNKNOWN. THE REPORTER CONSIDERED NUTRINEAL AS SUSPECT .

    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 67 YR Required Intervention UVEDOSE,CALCIDIA,NOVOMIX 30, MIMPARA 30 MG| TAHOR 10 MG ,VASTAREL 35 MG ,CREON, RENAGEL| EXTRANEAL VIAFLEX, PHYSIONEAL 40