BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HC CYCLER

    MDR report key: 2981604 · Received February 27, 2013

    Report

    Report Number
    1416980-2013-04869
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 1, 2013
    Report Date
    February 5, 2013
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AN INTERNAL INVESTIGATION IS CURRENTLY UNDER WAY, HOWEVER HAS NOT YET BEEN COMPLETED. ONCE THE EVALUATION IS COMPLETE, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE REPORTED ISSUE WITH REGARDS TO THE DEVICE COULD NOT BE CONFIRMED. THE ASSIGNABLE CAUSE WAS UNDETERMINED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT WAS RECEIVED FROM GLOBAL PHARMACOVIGILANCE (GPV) AND IS A SPONTANEOUS REPORT FROM A CONSUMER WITH SUPPLEMENTAL INFORMATION RECEIVED BY A NURSE FROM (B)(6) A HOME PATIENT WITH FLUID IN THE LUNGS, AND A LUNG INFECTION COINCIDENT WITH DIANEAL THERAPY. ON AN UNREPORTED DATE, THE PATIENT EXPERIENCED A LUNG INFECTION AND FLUID IN THE LUNGS MANIFESTED BY CHEST PAIN. IT WAS REPORTED THAT THE FLUID IN THE LUNGS WAS FROM THE PERITONEAL DIALYSIS SOLUTION. ON AN UNKNOWN DATE, THE PATIENT WAS DISCHARGED. TREATMENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84192 HC CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1 DIANEAL PD4 1.5%