BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMECHOICE CYCLER-REFURBISHED

    MDR report key: 1981178 · Received February 8, 2011

    Report

    Report Number
    1423500-2011-01624
    Event Type
    Injury
    Date Received
    February 8, 2011
    Date of Event
    December 28, 2010
    Report Date
    December 28, 2010
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    FKX
    PMA / PMN Number
    K053512
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ASSIGNABLE CAUSE FOR THE REPORT OF A CAUTION NEGATIVE ULTRAFILTRATION ALARM AND DEVELOPMENT OF A HYDROTHORAX WAS UNDETERMINED. A SERVICE HISTORY REVIEW WAS PERFORMED ON THE DEVICE AND NO ISSUES WERE IDENTIFIED. THE DEVICE WAS NOT RETURNED TO BAXTER, PRECLUDING FURTHER DEVICE INVESTIGATION. RENAL QUALITY ENGINEERING, ALONG WITH PLANT SERVICING AND QUALITY PERSONNEL, WILL CONTINUE TO MONITOR PRODUCT LINES FOR TRENDS AND WILL TAKE CORRECTIVE/PREVENTIVE ACTION AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). THE PD NURSE DECLINED TO RETURN THE HOMECHOICE DEVICE FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON COMPLETION OF BAXTER'S INVESTIGATION.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A CAUTION NEGATIVE ULTRA FILTRATION ALARM, WHICH OCCURRED ON THE HOMECHOICE (HC) DURING USE DURING THE PREVIOUS THERAPY. THE CAREGIVER (CG) DISCONNECTED THE HOME PATIENT (HP) AND CALLED THE PERITONEAL DIALYSIS (PD) NURSE. THE PD NURSE SUGGESTED THE HP PERFORM A MANUAL DRAIN AND INJECT HEPARIN. THE CG STATED THE HP WAS NOT ABLE TO DRAIN MANUALLY EITHER. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE PD NURSE ON (B)(6) 2011. THE PD NURSE STATED THE HP HAD DEVELOPED A HYDROTHORAX AND WAS UNABLE TO RESUME THERAPY. THE HP WAS CURRENTLY ON HEMODIALYSIS. THE PD NURSE STATED THERE WAS LEAKAGE OF THE PD FLUID AND POSSIBLE PROBLEMS WITH THE DIAPHRAGM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention