BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RENAL - DISPOSABLE

    MDR report key: 1951040 · Received January 6, 2011

    Report

    Report Number
    1423500-2011-00179
    Event Type
    Injury
    Date Received
    January 6, 2011
    Date of Event
    December 1, 2010
    Report Date
    December 16, 2010
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    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. 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 PHARMACIST AND A PHYSICIAN FROM (B)(6) OF SEPTIC PERITONITIS WITH (B)(6) IN A (B)(6) FEMALE PATIENT COINCIDENT WITH EXTRANEAL VIAFLEX THERAPY. IN (B)(6) 2010, THE PATIENT BEGAN TREATMENT WITH EXTRANEAL VIAFLEX (DOSE NOT REPORTED, MOST RECENT LOT NUMBERS 10J15G37 AND 10I19G37) AND UNSPECIFIED FRESENIUS PERITONEAL DIALYSIS (PD) SOLUTIONS INTRAPERITONEALLY (IP) FOR CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD). THE PATIENT RECEIVED UNSPECIFIED FRESENIUS PD SOLUTIONS IN THE MORNING, AT MIDDAY, AND IN THE EVENING AND EXTRANEAL DURING THE NIGHT. ON (B)(6) 2010, THE PATIENT EXPERIENCED SEPTIC PERITONITIS WITH (B)(6). REMEDIAL TREATMENT CONSISTED OF VANCOMYCIN (DOSAGE AND DURATION UNSPECIFIED). LABORATORY TESTS WERE NOT REPORTED. ON AN UNREPORTED DATE IN (B)(6) 2010, THE PATIENT RECOVERED FROM THE SEPTIC PERITONITIS WITH (B)(6) WITHOUT CATHETER REMOVAL. THE ACTION TAKEN WITH EXTRANEAL WAS NOT REPORTED. UNSPECIFIED FRESENIUS PD SOLUTIONS WERE ALSO CONSIDERED SUSPECT. MEDICAL HISTORY AND CONCOMITANT MEDICATIONS WERE NOT REPORTED. THE REPORTING PHYSICIAN BELIEVED THE SEPTIC PERITONITIS WITH (B)(6) WAS NOT RELATED TO EXTRANEAL VIAFLEX.

    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 47 YR Required Intervention EXTRANEAL VIAFLEX AND UNSPECIFIED FRESENIUS PERITO