BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYSTEM 1000

    MDR report key: 2230706 · Received September 1, 2011

    Report

    Report Number
    1423500-2011-11539
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 12, 2011
    Report Date
    August 12, 2011
    Manufacturer
    BAXTER HEALTHCARE - LARGO
    Product Code
    KDI
    PMA / PMN Number
    K970446
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS EVALUATED ONSITE BY A BAXTER FIELD SERVICE ENGINEER. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW UP MDR WILL BE SENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED "AN ISSUE WITH ONE U0707 TINA SINGLE PUMP (B)(4), SERIAL# UNKNOWN, PRODUCT CODE S1000L3P. THE CUSTOMER STATED THAT THE DEVICE FAILED AIR DETECTOR AND CANNOT BE RESET." THERE WAS NO PATIENT INVOLVEMENT. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED ALONG WITH THIS COMPLAINT. BECAUSE THE COMPLAINT COULD NOT BE CONFIRMED, ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    A NURSE REPORTED TO BAXTER (B)(4) THAT THE DEVICE FAILED AIR DETECTOR AND CANNOT BE RESET. THE PROCESS STEP IS UNKNOWN; PATIENT INVOLVEMENT OR INJURY ARE UNKNOWN. MEDICAL INTERVENTION IS UNKNOWN

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYSTEM 1000 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM KDI BAXTER HEALTHCARE - LARGO

    Patients

    Seq Age Sex Outcome Treatment
    1