BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4947018 · Received July 28, 2015

    Report

    Report Number
    1416980-2015-30462
    Event Type
    Death
    Date Received
    July 28, 2015
    Date of Event
    July 3, 2015
    Report Date
    July 7, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THIS REPORT IS FOR A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT A PATIENT WHO EXPERIENCED A PREVIOUSLY REPORTED PERITONITIS EVENT SUBSEQUENTLY PASSED AWAY COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE CAUSE OF DEATH WAS UNKNOWN. IT WAS UNKNOWN IF THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT PRIOR TO DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. DIANEAL THERAPIES WERE ONGOING UP UNTIL THE TIME OF DEATH, BUT IT WAS NOT REPORTED IF THE PATIENT WAS PERFORMING THERAPY WITH BAXTER HEALTHCARE DISPOSABLES AND/OR BAXTER HEALTHCARE SOLUTIONS AT THE TIME OF DEATH. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS THERAPY. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT MADE A MISTAKE. FOUR DAYS AFTER ONSET THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT WITH INTRAPERITONEAL (IP) VANCOMYCIN 1GM (FREQUENCY AND DURATION NOT REPORTED), IP CEFAZOLINE 1GM ONCE A DAY (DURATION NOT REPORTED) AND IP CEFTAZIDIME 1GM ONCE A DAY (DURATION NOT REPORTED) FOR PERITONITIS. DIANEAL THERAPIES WERE ONGOING. AT THE TIME OF THIS REPORT THE PATIENT OUTCOME WAS UNKNOWN. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    488381 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| H| R