BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10327980 · Received July 27, 2020

    Report

    Report Number
    1416980-2020-04340
    Event Type
    Injury
    Date Received
    July 27, 2020
    Report Date
    July 27, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STUDY WAS CONDUCTED FROM DECEMBER 2010 TO JANUARY 2018. LITERATURE ARTICLE: SILVA, S., ADELINA, E., PEREIRA, B., CORDEIRO, L., RODRIGUES, C, DUARTE, R, ABENSUR, H., ELIAS, R. ¿EARLY START PERITONEAL DIALYSIS: TECHNIQUE SURVIVAL IN LONG-TERM FOLLOW-UP¿. KIDNEY BLOOD PRESS RES (2018) 43:1699-1705. DOI: 10.1159/000495386. 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

    AN UNSPECIFIED NUMBER OF AUTOMATED PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED PERITONITIS. THE CAUSE AND TREATMENT FOR THE EVENTS WERE NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WERE HOSPITALIZED FOR THE EVENTS. 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
    790519 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other HOMECHOICE OR PD-NIGHT PD MACHINE (FRESENIUS)| LACTATE-BUFFERED GLUCOSE DIALYSATE| TENCKHOFF PD CATHETER