BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 4243446 · Received November 11, 2014

    Report

    Report Number
    1416980-2014-39899
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 16, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    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 CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS DESCRIBED AS TOUCH CONTAMINATION. THE PATIENT WAS HOSPITALIZED FOR THE PERITONITIS AND WAS FIRST TREATED WITH UNSPECIFIED ANTIBIOTICS INTRAPERITONEALLY (DOSE AND FREQUENCY NOT REPORTED). THE CATHETER WAS LATER REMOVED AND THE PATIENT WAS TEMPORARILY PLACED ON HEMODIALYSIS THERAPY. AT THAT TIME, THE PATIENT WAS SWITCHED TO INTRAVENOUS ANTIBIOTICS (DOSE AND FREQUENCY NOT REPORTED). THE HEMODIALYSIS TREATMENT WAS ONGOING, UNTIL THE PATIENT MEETS WITH A SURGEON AND GETS THE PD CATHETER PLACED. THE PATIENT HAD BEEN DISCHARGED FROM THE HOSPITAL AND THEY WERE REPORTED TO HAVE RECOVERED FROM THE PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725334 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R AUTOMATED PD SET WITH CASSETTE, TITANIUM ADAPTER| DRAINAGE BAGS| DIANEAL 2.5% PD4 AMBUFLEX, HOMECHOICE, MINICAP