BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10320994 · Received July 24, 2020

    Report

    Report Number
    1416980-2020-04276
    Event Type
    Injury
    Date Received
    July 24, 2020
    Report Date
    July 24, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS RECEIVED FROM A STUDY. BASU B;, MAHAPATRA TKS;, ROY B;, SCHAEFER F: EFFICACY AND OUTCOMES OF CONTINUOUS PERITONEAL DIALYSIS VERSUS DAILY INTERMITTENT HEMODIALYSIS IN PEDIATRIC ACUTE KIDNEY INJURY. DOI 10.1007/S00467-016-3412-7. PEDIATR NEPHROL. 23 FEBRUARY 2016 /REVISED: 27 MARCH 2016 /ACCEPTED: 22 APRIL 2016. IT WAS REPORTED THAT THE EVENT OCCURRED ON AN UNREPORTED DATE IN (B)(6) 2013 TO AN UNREPORTED DATE IN (B)(6) 2015. 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, FIVE PEDIATRIC PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED PERITONITIS. THE CAUSE WAS NOT REPORTED. IT WAS NOT REPORTED IF THE PATIENTS WAS HOSPITALIZED FOR THE EVENT. THE PATIENTS WERE TREATED WITH AN UNSPECIFIED ANTIBIOTICS FOR THE EVENT. AT THE TIME OF THIS REPORT, THE PATIENT'S 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
    784849 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Other DIANEAL PD SOLUTION| HOMECHOICE PRO CYCLER