BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4220153 · Received November 3, 2014

    Report

    Report Number
    1416980-2014-38447
    Event Type
    Injury
    Date Received
    November 3, 2014
    Date of Event
    September 5, 2014
    Report Date
    October 8, 2014
    Manufacturer
    BAXTER HEATHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CAUSE OF THIS PERITONITIS WAS USE ERROR REPORTED TO BE DUE TO A BREAK IN ASEPTIC TECHNIQUE BY THE PATIENT. 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. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT EXPERIENCED A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH RESULTED IN PERITONITIS. THE PERITONITIS WAS MANIFESTED BY ABDOMINAL PAIN. EIGHT DAYS AFTER THE ONSET OF PERITONITIS, THE PATIENT WAS HOSPITALIZED FOR THE EVENT FOR 5-6 DAYS. THE PATIENT WAS TREATED WITH AN UNSPECIFIED INTRAVENOUS (IV) ANTIBIOTIC WHILE HOSPITALIZED AND VANCOMYCIN INTRAPERITONEALLY (IP) (DOSE AND FREQUENCY UNKNOWN) AFTER DISCHARGE FROM THE HOSPITAL FOR THE PERITONITIS EVENT. THE CAUSE OF THE PERITONITIS WAS REPORTED BY THE PATIENT TO BE UNKNOWN, HOWEVER, THE NURSE REPORTED THE CAUSE TO BE DUE TO A BREACH IN ASEPTIC TECHNIQUE. ON AN UNREPORTED DATE, THE PATIENT RECOVERED FROM THE PERITONITIS EVENT. ON AN UNREPORTED DATE, THE PATIENT WAS RETRAINED IN ASEPTIC TECHNIQUE. PD THERAPY WAS ONGOING. ADDITIONAL INFORMATION WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701416 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEATHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R 1.5% DIANEAL PD4 SINGLEBAG| 2.5% DIANEAL PD4 SINGLEBAG,