BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    MDR report key: 2991665 · Received March 6, 2013

    Report

    Report Number
    1416980-2013-05440
    Event Type
    Malfunction
    Date Received
    March 6, 2013
    Date of Event
    February 23, 2013
    Report Date
    February 23, 2013
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE PROBLEM WAS NOT CONFIRMED. THE ROOT CAUSE WAS UNDETERMINED. BAXTER?S ATTEMPTS TO OBTAIN THE SAMPLE AND LOT NUMBER WERE UNSUCCESSFUL, AND THEREFORE, AN EVALUATION AND BATCH REVIEW COULD NOT BE PERFORMED. A FOLLOW UP REPORT WILL BE FILED IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED GLOBAL TECHNICAL SERVICES (GTS) REGARDING A SYSTEM ERROR 2367 THAT APPEARED ON THE HOME CHOICE (HC) DURING DWELL 7 OF 9. THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT INJURY OR MEDICAL INTERVENTION INDICATED AT THE TIME OF THE INITIAL REPORT. PRODUCT SURVEILLANCE CONTACTED THE HOME PATIENT'S NURSE WHO SAID THAT HE WAS NOT AWARE OF THE PATIENT HAVING HAD THAT ALARM. HE SAID HE WAS NOT THE PATIENT'S PRIMARY NURSE. HE SAID AS FAR AS HE KNEW, THE PATIENT HAS BEEN COMPLETING THERAPY SUCCESSFULLY, EXCEPT THAT THE PATIENT IS CURRENTLY IN THE HOSPITAL. HE SAID SHE IS IN THE HOSPITAL FOR BLOOD IN THE PERITONEUM. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95013 SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 HOME CHOICE