BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERITONEAL CATHETER

    MDR report key: 11847859 · Received May 19, 2021

    Report

    Report Number
    3009211636-2021-00111
    Event Type
    Injury
    Date Received
    May 19, 2021
    Date of Event
    October 15, 2020
    Report Date
    May 19, 2021
    Manufacturer
    COVIDIEN MFG SOLUTIONS S.A.
    Product Code
    FJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: RISK FACTORS FOR PERITONEAL DIALYSIS WITHDRAWAL DUE TO PERITONEAL DIALYSIS-RELATED PERITONITIS SOURCE: NE´PHROLOGIE & THE´RAPEUTIQUE 17 (2021) 108¿113 ACCEPTED 15 OCTOBER 2020. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE LITERATURE SOURCE OF STUDY, THIS RETROSPECTIVE ANALYSIS EVALUATED CLINICAL CHARACTERISTICS, LABORATORY DATA, AND CAUSATIVE MICROORGANISMS OF 204 EPISODES OF PERITONEAL DIALYSIS-RELATED PERITONITIS BETWEEN 2007 AND 2018. OF THESE, 38 CASES WITHDREW FROM PD (PERITONEAL DIALYSIS) DUE TO PERITONITIS. ALL CASES UNDERWENT PD WITH A DOUBLE-CUFFEDAND STRAIGHT CATHETER. THE DIALYSATE CULTURE SHOWED THAT STAPHYLOCOCCUS SPECIES WERE THE MOST FREQUENTLY OCCURRING GRAM-POSITIVE BACTERIA. PSEUDOMONAS AERUGINOSA WAS THE MOST FREQUENTLY OCCURRING GRAM-NEGATIVE BACTERIUM. FUNGI (CANDIDA SPECIES) WERE SEEN IN 5 CASES IN THE WITHDRAWAL GROUP. FOR THE EMPIRICAL TREATMENT OF PERITONITIS, CEFAZOLIN SODIUM AND ISEPAMICIN SULFATE WERE USED PRIOR TO PD CATHETERIZATION. THEREAFTER, THE ANTIBIOTICS WERE DE-ESCALATED ACCORDING TO THE CULTURE RESULTS OR SWITCHED TO VANCOMYCIN HYDROCHLORIDE AND MEROPENEM HYDRATE IF THE SYMPTOMS WORSENED. ANTIBIOTICS WERE INTRAVENOUSLY ADMINISTERED AND CONTINUED FOR AT LEAST 2 WEEKS IN THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    743534 PERITONEAL CATHETER CATHETER, PERITONEAL, LONG-TERM INDWELLING FJS COVIDIEN MFG SOLUTIONS S.A. PERITONEAL CATHETER

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R