BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    MDR report key: 3760149 · Received April 18, 2014

    Report

    Report Number
    1416980-2014-12726
    Event Type
    Injury
    Date Received
    April 18, 2014
    Report Date
    March 26, 2014
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    KDJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EXACT DATE WAS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT EXPERIENCED PERITONITIS IN SOMETIME IN (B)(6) 2014. 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 FORMAL 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 (PT) HAD A BREAK IN ASEPTIC TECHNIQUE DURING PERITONEAL DIALYSIS (PD) THERAPY WHICH CAUSED PERITONITIS. THE BREAK IN ASEPTIC TECHNIQUE WAS FURTHER DESCRIBED AS THE PT WAS SENT HOME FROM CATHETER IMPLANT SURGERY WITHOUT AN END CAP WHICH LED TO PERITONITIS. ON AN UNREPORTED DATE, TWO MONTHS PRIOR TO THE RECEIPT OF THIS REPORT, THE PT WAS HOSPITALIZED FOR THE EVENT. ON AN UNREPORTED DATE, THE PT BEGAN TREATMENT WITH VANCOMYCIN (1 GRAM, 3 TIMES A WEEK, INTRAVENOUSLY (IV)) IN THE PD CLINIC, FORTAZ (1 GRAM, ONE DOSE, INTRAPERITONEAL (IP)), AND ANCEF (1 GRAM, ONE DOSE, IP) FOR PERITONITIS. IN THE SAME MONTH AS ADMISSION, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON AN UNREPORTED DATE, PD THERAPY WAS DISCONTINUED. AT THE TIME OF THIS REPORT, THE PT HAD RECOVERED FROM PERITONITIS. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236990 SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE KDJ BAXTER HEALTHCARE CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R DIANEAL PD4 2.5% AMBUFLEX| DIANEAL PD4 1.5% AMBUFLEX| DIANEAL PD4 4.25% AMBUFLEX