BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE

    MDR report key: 3843933 · Received June 2, 2014

    Report

    Report Number
    1416980-2014-17678
    Event Type
    Injury
    Date Received
    June 2, 2014
    Report Date
    May 8, 2014
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K102936
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED ON AN UNSPECIFIED DATE IN 1994. A REVIEW OF THE DEVICE HISTORY RECORD WAS PERFORMED. UPON PERFORMING THIS REVIEW, NO ISSUE WAS FOUND THAT COULD BE RELATED TO THE REPORTED EVENT. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A FOLLOW-UP WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS MANUFACTURED IN 1994. THE DEVICE WAS RETURNED TO BAXTER HEALTHCARE FOR FURTHER INVESTIGATION. A REVIEW OF THE EVENT HISTORY LOG IDENTIFIED A CHECK PATIENT LINE, LOW UF, LOW DRAIN/LOW DRAIN VOLUME AND BATTERY FAILED ALARM. THE RESULTS OF THE SAMPLE ANALYSIS REVEALED THAT DURING VISUAL INSPECTION FOUND NO BACKLIGHTS. THE POWER ON SELF-TEST CANNOT BE COMPLETED DUE TO LOW BATTERY INDICATION. THE ONE HOUR THERAPY WAS COMPLETED WITHOUT ERROR OR ALARM. THE DEVICE WAS SERVICED AND SUBSEQUENTLY PASSED ALL TESTS. A REVIEW OF THE DEVICE HISTORY REVEALED NO NONCONFORMITIES, FAILURES, REWORK OR DEVIATIONS DURING THE MANUFACTURING PROCESS THAT WOULD CAUSE OR CONTRIBUTE TO THE REPORTED PROBLEM. THERE WAS NO NON-CONFORMING PRODUCT IDENTIFIED RELATED TO THE REPORTED PROBLEM. THE CAUSE OF THE REPORTED PROBLEM WAS UNDETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PERITONEAL DIALYSIS (PD) PATIENT (PT), WHO PERFORMS PD THERAPY WITH A HOMECHOICE (HC) DEVICE, DEVELOPED A HERNIA. IT WAS NOT REPORTED WHETHER THE PT WAS HOSPITALIZED FOR THE EVENT. THE CAUSE AND THE LOCATION OF THE HERNIA WAS NOT REPORTED. TREATMENT AND THE PT¿S OUTCOME WAS NOT REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ADDITIONAL INFORMATION WAS REQUESTED BUT IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321200 HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1 Other