BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4862638 · Received June 23, 2015

    Report

    Report Number
    1416980-2015-26300
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 5, 2015
    Report Date
    June 4, 2015
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS UNKNOWN, THEREFORE A DEVICE ANALYSIS COULD NOT BE PERFORMED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY EXTREME ABDOMINAL PAIN. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. IT WAS REPORTED THE PATIENT WAS HOSPITALIZED FOR THE EVENT THREE DAYS AFTER DIAGNOSIS. ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH UNKNOWN INTRAPERITONEAL ANTIBIOTICS (DOSE, FREQUENCY AND DURATION NOT REPORTED). ON AN UNKNOWN DATE THE PATIENT WAS TREATED WITH UNKNOWN ORAL ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED) FOR THE PERITONITIS. THE ORAL ANTIBIOTICS WERE DISCONTINUED APPROXIMATELY ONE WEEK PRIOR TO RECEIPT OF THIS REPORT. THE PATIENT WAS DISCHARGED TWELVE DAYS AFTER ADMISSION AND MOVED TO A "STEP-DOWN SPECIALTY HOSPITAL¿. ACTION WITH DIANEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND WAS RECOVERING FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406180 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R HOMECHOICE, EXTRANEAL SOLUTIONS| DIANEAL PD4 1.5% AND 2.5% SINGLEBAG SOLUTIONS