BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2033564 · Received March 30, 2011

    Report

    Report Number
    1423500-2011-03832
    Event Type
    Injury
    Date Received
    March 30, 2011
    Date of Event
    October 1, 2010
    Report Date
    March 10, 2011
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A REGULATORY REPORT FROM (B)(6) WITH SUPPLEMENTAL INFORMATION FROM A PHYSICIAN OF BACTERIAL PERITONITIS WITH A CULTURE (B)(6) EPIDERMIDIS IN A PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). IN (B)(6) 2010, THE PATIENT EXPERIENCED BACTERIAL PERITONITIS. TREATMENT, OUTCOME AND ACTION TAKEN WITH EXTRANEAL WAS NOT REPORTED. OTHER RELATED CASES INCLUDED CLINICALLY BACTERIAL PERITONITIS WITH (B)(6) RESULT FROM CULTIVATION IN (B)(6) 2011. THE REGULATORY AUTHORITY AND PHYSICIAN DID NOT PROVIDE A CAUSALITY ASSESSMENT FOR THE EVENT OF BACTERIAL PERITONITIS WITH CULTURE POSITIVE FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY KDJ BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Other MINISUN+CALICIUM (CALCIUM WITH VITAMIN D)| SIMVASTATIN| ARANESP| FURESIS| SELOKEN| RENAPRO POWDER| RENAVIT| ATARAX| LEVEMIR FLEXPEN (INSULIN DETEMIR)| HUMALOG| BALANCE STAY SAFE 1,50 AND 2,30| PLENDIL| PANADOL| ATARAX (HYDROXYZINE)| PARA-TABS 500MG| GEFILUS| LAKTULOS| PLAVIX| CIPRALEX| EMGESAN| EXTRANEAL VIAFLEX| KALSIPOS| TENOX| ETALPHA