BEUDAMED
    FDA Adverse Event Death Summary report: N

    NI

    MDR report key: 5999574 · Received October 5, 2016

    Report

    Report Number
    1416980-2016-15938
    Event Type
    Death
    Date Received
    October 5, 2016
    Date of Event
    September 11, 2016
    Report Date
    October 5, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS A CHANGE IN CARETAKER. THE REPORTER STATED THAT PATIENT'S SPOUSE USED TO DO THE DIALYSIS BUT THEY WERE NOT WELL; THEREFORE, ANOTHER FAMILY MEMBER WAS PERFORMING THE DIALYSIS AND THIS PERSON WAS NOT TRAINED. THE SAME DAY AS THE ONSET OF PERITONITIS; THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) INJECTION OF VANCOMYCIN (500MG, FREQUENCY AND DURATION NOT REPORTED) AND IP INJECTION OF AMIKACIN (250MG ONCE A DAY, DURATION NOT REPORTED) FOR PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT WAS RETRAINED ON THE PROPER ASEPTIC TECHNIQUE. IT WAS UNKNOWN IF THE PERITONITIS WAS RESOLVED. ON AN UNKNOWN DATE THE PATIENT PASSED AWAY. THE CAUSE OF DEATH WAS REPORTED AS DUE TO CARDIAC ARREST. AN AUTOPSY WAS NOT PERFORMED. IT WAS NOT REPORTED IF THERAPY WAS ONGOING PRIOR TO DEATH OR IF THE PATIENT WAS PERFORMING THERAPY AT THE TIME OF DEATH. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652776 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Death| H| R DIANEAL 2.5% PD4