BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7050275 · Received November 21, 2017

    Report

    Report Number
    1416980-2017-09250
    Event Type
    Injury
    Date Received
    November 21, 2017
    Date of Event
    October 25, 2017
    Report Date
    November 21, 2017
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    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

    AN AUTOMATED PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED A BREACH IN ASEPTIC TECHNIQUE WHICH RESULTED IN FUNGAL PERITONITIS. THE BREACH IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS ¿PERFORMED PD THERAPY IN UNCLEAN CONDITIONS¿. THE PERITONITIS WAS MANIFESTED BY CLOUDY PD EFFLUENT AND ABDOMINAL PAIN. THE SAME DAY AS EVENT ONSET OF THE PERITONITIS; THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS EVENT. THE SAME DAY AS HOSPITALIZATION THE PATIENT WAS TREATED WITH INTRAPERITONEAL (IP) CEFAMEZIN (0.5G, FREQUENCY AND DURATION NOT REPORTED) AND ¿PS¿(20ML) AND IP HEPARIN (1CC, FREQUENCY AND DURATION NOT REPORTED) THE FOLLOWING DAY THE PATIENT WAS TREATED WITH , LIASOPHIN ("1G X 2V¿, FOR SEVEN DAYS, FREQUENCY AND ROUTE UNREPORTED). EIGHT DAYS AFTER EVENT ONSET, CEFDINIR (DOSE, FREQUENCY, DURATION AND ROUTE NOT REPORTED) TREATMENT WAS STARTED. PD THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT, THE PATIENT WAS RECOVERING FROM THIS EVENT. ON AN UNREPORTED DATE, THE PD EFFLUENT BECAME CLEAR AND THE ABDOMINAL PAIN SUBSIDED. IT WAS REPORTED THE PATIENT WAS SCHEDULED TO BE RETRAINED ON PROPER ASEPTIC TECHNIQUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827221 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R DIANEAL PD4 1.5%| HOMECHOICE| REGUNEAL HCA 2.5%