BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4251024 · Received November 14, 2014

    Report

    Report Number
    1416980-2014-40576
    Event Type
    Injury
    Date Received
    November 14, 2014
    Date of Event
    October 17, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER HEALTHCARE - SWINFORD
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PATIENT¿S HEIGHT WAS REPORTED AS 173 CM. THE REPORTED PRODUCT IS AN UNKNOWN BAXTER TITANIUM ADAPTER. 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. THIS REPORT REFERENCES THE SAME PATIENT AS (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED A PATIENT EXPERIENCED PERITONITIS COINCIDENT WITH PERITONEAL DIALYSIS (PD) THERAPY. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN AND TURBID DRAINAGE. THE CAUSE OF THE PERITONITIS WAS UNKNOWN. THE SAME DAY THE PATIENT PRESENTED TO AN OUTPATIENT CLINIC AND WAS TREATED WITH FORTUM (DOSE, ROUTE AND FREQUENCY NOT REPORTED) AND INTRAPERITONEAL (IP) CEFAZOLIN (1 GRAM ONCE A DAY). BOTH ANTIBIOTICS WERE DISCONTINUED THE FOLLOWING DAY. TWO DAYS AFTER ONSET THE PATIENT PRESENTED TO THE EMERGENCY ROOM AND WAS HOSPITALIZED FOR THE PERITONITIS. THE SAME DAY THE PATIENT BEGAN TREATMENT WITH IP AMIKTAM (250 MILLIGRAM ONCE A DAY), IP VANCOMYCIN (1000 MILLIGRAM ONCE A DAY) AND INTRAVENOUS MEROPENEM (500 MILLIGRAM ONCE A DAY) FOR PERITONITIS. ANTIBIOTIC THERAPY REMAINS ONGOING. PHYSIONEAL THERAPY WAS ONGOING. AT THE TIME OF THIS REPORT THE PATIENT REMAINED HOSPITALIZED AND WAS NOT RECOVERED FROM THIS PERITONITIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3 INVOLVED IN THIS PERITONITIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    736319 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE - SWINFORD

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R PHYSIONEAL 2.5%, TRANSFER SET, MINICAP