BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3841573 · Received May 30, 2014

    Report

    Report Number
    1416980-2014-17485
    Event Type
    Injury
    Date Received
    May 30, 2014
    Report Date
    May 7, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - OCCURRENCE DATE WAS REPORTED TO BE AN UNKNOWN DATE AT THE END OF (B)(6) 20134A REQUEST FOR THE RETURN OF THE DEVICE HAS BEEN MADE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH THERAPY FOR PERITONEAL DIALYSIS. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THERAPY WAS NOT ONGOING. IT WAS REPORTED THAT THE PERITONITIS WAS MANIFESTED BY STOMACH PAIN AND VOMITING. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS TREATED WITH UNSPECIFIED ANTIBIOTICS FOR THE EVENT (DOSE, ROUTE, AND FREQUENCY UNKNOWN). IT WAS REPORTED THAT AFTER SEVEN WEEKS THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE PATIENT WAS REPORTED TO BE RECOVERING FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318420 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R DIANEAL 2.5%