BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4180873 · Received October 17, 2014

    Report

    Report Number
    1416980-2014-36236
    Event Type
    Injury
    Date Received
    October 17, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 23, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR. PER BAXTER LABELING, USERS ARE INSTRUCTED TO USE ASEPTIC TECHNIQUE WHEN PERFORMING PERITONEAL DIALYSIS THERAPY. A REVIEW OF THE LABEL FOR THE PRODUCT FAMILY WILL BE CONDUCTED. THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) WHICH CAUSED PERITONITIS MANIFESTED BY ABDOMINAL PAIN AND CLOUDY EFFLUENT. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PATIENT HAD AN EPISODE OF HYPOGLYCEMIA, BECAME CONFUSED, AND FORGOT TO PUT A MINICAP ON THE TRANSFER SET WHEN DISCONNECTING. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS. ON AN UNREPORTED DATE THE PATIENT WAS TREATED WITH VANCOMYCIN 2 GRAMS INTRAPERITONEALLY OF FIVE DOSES TOTAL (FREQUENCY AND DURATION NOT REPORTED) FOR THE PERITONITIS. AFTER BEING HOSPITALIZED FOR SEVEN DAYS, THE PATIENT WAS DISCHARGED. THE PATIENT WAS RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED ON PROPER ASEPTIC TECHNIQUE. DIANEAL THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662595 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R DIANEAL PD4 AMBUFLEX 2.5%, HOMECHOICEPRO