BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4250211 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40297
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 20, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PO
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TRANSFER SET. THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN, THEREFORE, A DEVICE ANALYSIS CANNOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED. SAME PATIENT AS (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). UPON FOLLOW UP, IT WAS REPORTED THAT ANTIBIOTIC TREATMENT HAD BEEN DISCONTINUED AND THE PATIENT WAS REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (PD) THERAPY MANIFESTED BY ABDOMINAL PAIN, FEVER, VOMITING, AND CLOUDY PD EFFLUENT. THE CAUSE OF THE PERITONITIS IS UNKNOWN. ON THE SAME DAY AS ONSET, THE PATIENT WAS HOSPITALIZED FOR THE EVENT. ON THE SAME DAY AT 13.00 HOUR, THE PATIENT BEGAN TREATMENT FOR THE PERITONITIS WITH CEFAZOLIN AND CEFTAZIDIME (125 MG/LITERS, 4 TIMES PER DAY) INTRAPERITONEALLY. AT THE TIME OF THIS REPORT, ANTIBIOTIC THERAPY WAS ONGOING. ONE DAY AFTER ONSET OF THE PERITONITIS, DUE TO PCR RESULT INCREASE TO 30, THE PATIENT BEGAN TREATMENT WITH TAZOBAC (2.25 GRAMS, INTRAVENOUSLY, 3 TIMES PER DAY). TWO DAYS LATER, WHEN THE PERITONEAL CULTURE RESULTS WERE KNOWN, THE TREATMENT WITH CEFAZOLIN, CEFTAZIDIME AND TAZOBAC WERE DISCONTINUED. ON THE SAME DATE, THE PATIENT STARTED TREATMENT WITH AMPICILLIN (250 MG, INTRAPERITONEALLY, 4 TIMES PER DAY) FOR AN UNKNOWN INDICATION. ONE WEEK AFTER BEING ADMITTED, THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. AT THE TIME OF THIS REPORT, THE PERITONITIS WAS RESOLVING, THE PATIENT WAS RECOVERING AND EXTRANEAL/PHYSIONEAL THERAPIES WERE ONGOING. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 3 INVOLVED IN THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737814 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R EXTRANEAL, PHYSIONEAL, TITANIUM ADAPTER, MINICAP