BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11939310 · Received June 4, 2021

    Report

    Report Number
    1416980-2021-03350
    Event Type
    Injury
    Date Received
    June 4, 2021
    Report Date
    July 29, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: B4/F8: DATE OF THIS REPORT IN THE INITIAL MDR IS BEING CORRECTED FROM BLANK TO 06/04/2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS RECEIVED FROM A LITERATURE ARTICLE. LITERATURE ARTICLE: JIANTENG XIE, HUIZHEN WANG, SHENG LI, YANGYANG ZUO, YANHUI WANG, YIFAN ZHANG, TIANTIAN LIANG, JING LI, LIPING WANG, ZHONGLIN FENG, ZHIMING YE, XINLING LIANG, WEI SHI AND WENJIAN WANG, "LOW-VOLUME TIDAL PERITONEAL DIALYSIS IS A PREFERABLE MODE IN PATIENTS INITIATING URGENT-START AUTOMATED PERITONEAL DIALYSIS: A RANDOMIZED, OPEN-LABEL, PROSPECTIVE CONTROL STUDY". THERAPEUTIC APHERESIS AND DIALYSIS 2019; 23(5):409¿417, 2019 INTERNATIONAL SOCIETY FOR APHERESIS, JAPANESE SOCIETY FOR APHERESIS, AND JAPANESE SOCIETY FOR DIALYSIS THERAPY. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; 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

    A STUDY WAS PERFORMED INVOLVING 49 AUTOMATED PERITONEAL DIALYSIS (APD) PATIENTS. TWO PATIENTS EXPERIENCED PERITONITIS. THE CAUSE AND TREATMENT FOR THE EVENTS WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT OUTCOME AND ACTION TAKEN WITH PD THERAPY WERE NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837365 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOMECHOICE CYCLER| TENCKHOFF CATHETER| HOMECHOICE CYCLER| TENCKHOFF CATHETER