BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3802736 · Received May 9, 2014

    Report

    Report Number
    1416980-2014-14972
    Event Type
    Death
    Date Received
    May 9, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 14, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS IS A REPORT OF A PATIENT WHO EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE RESULTING IN PERITONITIS. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A FORMAL REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS AND THE PT SUBSEQUENTLY PASSED AWAY. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS PT MADE A MISTAKE AND HAD A BREAK IN ASEPTIC TECHNIQUE. ON THE SAME DAY, THE PT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH INJECTION VANCOMYCIN (1GRAM, LOADING DOSE, INTRAPERITONEALLY (IP)) FOR PERITONITIS. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH INJECTION AMIKACIN (750MG, DAILY, IP) FOR PERITONITIS. IT WAS REPORTED THAT THE PT RECOVERED FROM PERITONITIS BUT THIS WAS NOT MEDICALLY CONFIRMED. ON AN UNREPORTED DATE, THE PT EXPERIENCED SEPSIS. THE CAUSE OF AND TREATMENT FOR SEPSIS WAS NOT REPORTED. TEN DAYS AFTER THE ONSET OF PERITONITIS, THE PT DIED DUE TO SEPSIS. PD THERAPY WAS ONGOING UNTIL THE TIME OF DEATH. IT WAS NOT REPORTED IF AN AUTOPSY WAS PERFORMED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280372 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Death| H| R DIANEAL 2.5% ULTRABAG, DIANEAL 1.5% ULTRABAG