BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 11827021 · Received May 14, 2021

    Report

    Report Number
    1416980-2021-02908
    Event Type
    Injury
    Date Received
    May 14, 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
    CO
    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 05/14/2021.

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS RECEIVED FROM A LITERATURE ARTICLE: ALFONSO BUNCH, JASMIN I. VESGA, DAVID O. CAMARGO, LEYDER CORZO, ALEJANDRA P. MOLANO, MARTHA E. DEVIA, MARIA C. RIOS, CLAUDIA P. RODRIGUEZ, RICARDO SANCHEZ, ANGELA S. RIVERA AND RAFAEL M. SANABRIA, "REMOTE AUTOMATED PERITONEAL DIALYSIS MANAGEMENT IN COLOMBIA", KIDNEY INT REP (2019) 4, 873¿876; HTTPS://DOI.ORG/10.1016/J.EKIR.2019.03.017 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

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722283 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOMECHOICE| HOMECHOICE