BEUDAMED
    FDA Adverse Event Death Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4032461 · Received August 25, 2014

    Report

    Report Number
    1416980-2014-27864
    Event Type
    Death
    Date Received
    August 25, 2014
    Report Date
    July 30, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED PERITONITIS. THE CAUSE OF THIS PERITONITIS WAS USE ERROR. 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. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. 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 PERITONITIS MANIFESTED BY ABDOMINAL PAIN COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE CAUSE OF THE PERITONITIS WAS A TOUCH CONTAMINATION DUE TO A BREAK IN ASEPTIC TECHNIQUE. TWO DAYS PRIOR TO THE PERITONEAL EFFLUENT CULTURE BEING PERFORMED AND TWO DAYS AFTER THE PERITONEAL EFFLUENT CULTURE WAS PERFORMED, THE PATIENT WAS TREATED WITH VANCOMYCIN 1.5GM INTRAPERITONEALLY (FREQUENCY AND DURATION NOT REPORTED) FOR THE PERITONITIS. IT WAS NOT REPORTED IF THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. IT WAS ALSO REPORTED THAT THE PATIENT PASSED AWAY WHILE IN THE HOSPITAL. THE PATIENT WAS HOSPITALIZED DUE TO AN UNRELATED CONDITION A WEEK PRIOR TO THE REPORTED DEATH. DURING THE HOSPITALIZATION, THE PATIENT HAD RESPIRATORY DISTRESS AND PASSED AWAY. TREATMENT FOR THE RESPIRATORY DISTRESS INCLUDED THE PATIENT BEING PLACED ON A VENTILATOR. DURING HOSPITALIZATION, DIANEAL THERAPY WAS ONGOING. IT WAS NOT REPORTED IF THE HP WAS PERFORMING THERAPY AT THE TIME OF DEATH. IT WAS NOT REPORTED IF THE HP WAS USING A HOMECHOICE(HC) CYCLER AT THE TIME OF DEATH. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513625 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R DIANEAL 2.5% AND 4.25% LOW CALCIUM SINGLEBAG| HOMECHOICE, DIANEAL 1.5%