BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4230878 · Received November 6, 2014

    Report

    Report Number
    1416980-2014-39092
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    September 30, 2014
    Report Date
    October 14, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VM
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THE PATIENT WAS BORN ON AN UNSPECIFIED DATE IN (B)(6). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. AS THE SAMPLE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, A DEVICE ANALYSIS CANNOT BE COMPLETED. (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS MANIFESTED BY ABDOMEN PAIN AND CLOUDY PERITONEAL DIALYSIS FLUIDS COINCIDENT WITH PERITONEAL CONTINUOUS AMBULATORY DIALYSIS THERAPY. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE PATIENT WAS HOSPITALIZED FOR THE EVENT. THE PATIENT WAS TREATED WITH CEFAZOLIN AND VANCOMYCIN (1 GRAM/DAY FOR 4 DAYS, IP); THE ROUTE WAS NOT REPORTED) AND THEN SWITCHED TO CIPRO (200 MILLIGRAM) (FREQUENCY, ROUTE, AND DURATION NOT REPORTED) AND TIENAM (1 GRAM/DAY, IP) (ROUTE AND DURATION NOT REPORTED) FOR THE PERITONITIS. AT THE TIME OF THIS REPORT, IT WAS UNKNOWN IF THE PATIENT WAS RECOVERING FROM THE PERITONITIS. HOWEVER, THE PATIENT REMAINED HOSPITALIZED. PD THERAPY WAS ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713653 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R TRANSFER SET, MINI CAP, DIANEAL PD4 1.5%, 2.5%