BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 10755744 · Received October 29, 2020

    Report

    Report Number
    1416980-2020-06712
    Event Type
    Injury
    Date Received
    October 29, 2020
    Report Date
    October 29, 2020
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE ARTICLE: YOUNG, G.A.; PARSONS, F.M.: THE EFFECT OF PERITONEAL DIALYSIS UPON THE AMINO ACIDS AND OTHER NITROGENOUS COMPOUNDS IN THE BLOOD AND DIALYSATES FROM PATIENTS WITH RENAL FAILURE. CLINICAL. SCI. 757.-1-10 (1969). 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, 15 PERITONEAL DIALYSIS (PD) PATIENTS EXPERIENCED 19 EPISODES OF PERITONITIS MANIFESTED BY CLOUDY EFFLUENT. THE CAUSE OF THE PERITONITIS WAS NOT REPORTED. IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF THE PATIENTS WERE HOSPITALIZED AND TREATED WITH UNSPECIFIED ANTIBIOTICS. PATIENT OUTCOMES WERE NOT REPORTED. IT WAS REPORTED THAT FIVE OF THE PATIENTS HAD THEIR CATHETERS REMOVED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1223838 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL