BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD

    MDR report key: 1980183 · Received February 7, 2011

    Report

    Report Number
    1423500-2011-01564
    Event Type
    Injury
    Date Received
    February 7, 2011
    Date of Event
    January 1, 2011
    Report Date
    January 14, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS BEEN RETURNED TO BAXTER, AND THE EVALUATION HAS BEGUN. A FOLLOW-UP REPORT SHALL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS PRODUCT IS DISTRIBUTED OUTSIDE THE U.S. AND DOES NOT HAVE A 510K NUMBER. THIS INCIDENT IS BEING REPORTED BECAUSE THE PRODUCT INVOLVED IS THE SAME AS OR SIMILAR TO PRODUCT DISTRIBUTED WITHIN THE U.S.

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT AND THERAPY LOGS WERE EVALUATED. THE DEVICE MEETS SPECIFICATION AND WORKS LIKE INTENDED. THE ROOT CAUSE OF COMPLAINT WAS NOT DETERMINED AS THE ISSUE WAS NOT CONFIRMED. ADDITIONAL DEVICE INFORMATION RECEIVED HAS BEEN REVIEWED IN DETAIL. THERE ARE NO VOLUMES REPORTED OR IN THE EVENT LOGS THAT FULFILL THE CRITERIA CONSISTENT WITH INCREASED INTRA-PERITONEAL VOLUME OR AN OVERFILL EVENT. BASED ON ADDITIONAL INFORMATION OBTAINED DURING BAXTER'S INVESTIGATION, THIS INCIDENT HAS BEEN DETERMINED NOT TO BE AN MDR REPORTABLE EVENT.

    Description of Event or Problem · 1

    THIS IS A CASE REPORTED TO BAXTER - (B)(4) REGARDING AN AUTOMATED PERITONEAL DIALYSIS (APD) HOME CHOICE PATIENT WHO WAS HOSPITALIZED FOR COMPLAINTS OF BREATHLESSNESS AND FEELING OVERLOADED. REPORTEDLY, THE PATIENT HAD TOO MUCH FLUID IN THE PERITONEUM. THE PATIENT HAS DISCONTINUED APD DUE TO HER LACK OF ABILITY AND IS CURRENTLY ON CAPD. THE OCCURRENCE DATE AND PATIENT OUTCOME IS UNKNOWN. THE DEVICE SHALL BE RETURNED TO DUBLIN TECHNICAL SERVICES FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLER 220 VOLT HOMECHOICE PROAUTOMATED PD SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization