BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 2071854 · Received April 28, 2011

    Report

    Report Number
    1423500-2011-05128
    Event Type
    Injury
    Date Received
    April 28, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 6, 2011
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    NURSE

    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

    BAXTER'S GLOBAL PHARMACOVIGILANCE (GPV) RECEIVED INFORMATION FROM A CUSTOMER WHO REPORTED THAT ON (B)(6) 2011, A PATIENT DEVELOPED CLOUDY EFFLUENT AND WAS DIAGNOSED WITH PERITONITIS. THE PATIENT NOTICED A DIANEAL BAG THAT APPEARED TO HAVE A COTTON SUBSTANCE IN THE BAG. THE PATIENT DID NOT USE THE BAG. IT WAS UNKNOWN IF THERE WERE OTHER DIANEAL BAGS THAT THE PATIENT HAD PREVIOUSLY SAID HAD COTTON SUBSTANCE IN THE BAG. A PD EFFLUENT CULTURE WAS PERFORMED THAT SAME DAY ALONG WITH WBC AND GRAM STAIN. ANTIBIOTIC THERAPY WAS STARTED SIMULTANEOUSLY. THERE WAS NO EXIT SITE OR TUNNEL INFECTION. THE PATIENT WAS NOT HOSPITALIZED. ON (B)(6) 2011, THE PATIENT WAS SEEN IN THE CLINIC. THE PD EFFLUENT WAS CLEAR. IT WAS POSSIBLE THE EVENT OF PERITONITIS WAS RELATED TO THE DIANEAL SOLUTION, BUT NOT CERTAIN. THE PATIENT REMAINED ON PD THERAPY; THE DOSE WAS NOT ALTERED. ON (B)(6) 2011, ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTER. THE REPORTER CALLED BAXTER WITH ADDITIONAL INFORMATION REGARDING THE PD EFFLUENT CULTURE RESULTS. ON (B)(6) 2011, THE PATIENT WAS STARTED ON VANCOMYCIN AND FORTAZ IP. WHEN THE GRAM STAIN REVEALED GRAM NEGATIVE RODS VANCOMYCIN WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE EVENT OF PERITONITIS WAS RESOLVING. THE PATIENT HAD CLEAR EFFLUENT. THE PATIENT REMAINED ON FORTAZ TREATMENT, NO CHANGE IN ANTIBIOTIC THERAPY. IT WAS UNKNOWN WHAT HAD CAUSED THE PERITONITIS. IT WAS UNKNOWN IF THE PERITONITIS WAS RELATED TO THE DIANEAL SOLUTIONS. NO FURTHER INFORMATION WAS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention VANCOMYCIN| FORTAZ