BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NI

    MDR report key: 7383690 · Received March 29, 2018

    Report

    Report Number
    1416980-2018-01693
    Event Type
    Injury
    Date Received
    March 29, 2018
    Report Date
    March 29, 2018
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    PMA / PMN Number
    NI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED RECURRENT PERITONITIS. THE CAUSE AND OUTCOME OF THE RECURRENT PERITONITIS WERE NOT REPORTED. ON AN UNREPORTED DATE, THE PATIENT BEGAN TREATMENT FOR THE RECURRENT PERITONITIS WITH INTRAPERITONEAL VANCOMYCIN, 3 GRAMS (FREQUENCY AND DURATION NOT REPORTED) AND UNSPECIFIED ORAL ANTIBIOTICS (NO FURTHER INFORMATION). IT WAS REPORTED THAT THE ANTIBIOTIC TREATMENT WAS ADMINISTERED VIA A HOMECHOICE CLARIA (NO FURTHER DETAIL). NO FURTHER DETAIL WAS PROVIDED REGARDING WHETHER THE PATIENT WAS HOSPITALIZED FOR THE EVENT. EXTRANEAL THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    223700 NI SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION NA NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention