BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    U0707 TINA SINGLE PUMP NIBPLCD

    MDR report key: 1243115 · Received November 21, 2008

    Report

    Report Number
    1423500-2008-00928
    Event Type
    Malfunction
    Date Received
    November 21, 2008
    Date of Event
    October 31, 2008
    Report Date
    November 3, 2008
    Manufacturer
    BAXTER HEALTHCARE
    Product Code
    FKP
    PMA / PMN Number
    K910215
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE FSE EVALUATED THE INSTRUMENT AND THERE WERE NO PROBLEMS FOUND. THE FSE DID NOT SEE SMOKE AND THERE WAS NO SMELL OF SMOKE. NO PARTS WERE REPLACED AND NO ADJUSTMENTS WERE MADE TO THIS INSTRUMENT BY THE FSE. THE INSTRUMENT WAS TESTED ACCORDING TO THE FUNCTIONAL DATA SHEET. THE INSTRUMENT RAN IN THE TREATMENT MODE FOR 2 HOURS WITHOUT ANY SMOKE SMELL OR SIGNS OF SMOKE. THE INSTRUMENT MEETS ALL FUNCTIONAL SPECIFICATIONS AND IS OPERATIONAL. THE INSTRUMENT IS READY FOR USE.

    Description of Event or Problem · 1

    A TECH MANAGER AT THE FACILITY CALLED BAXTER TECHNICAL SERVICE REGARDING A TINA HEMODIALYSIS INSTRUMENT. THE TECH MANAGER REPORTED THAT THE INSTRUMENT IS SMOKING. THIS OCCURRED DURING BIOMED TESTING. NO PT INJURY AND NO MEDICAL INTERVENTION WERE REPORTED. A FIELD SERVICE ENGINEER (FSE) WENT TO THE FACILITY AND STATED THAT HE WAS AT THE FACILITY TO EVALUATE THE INSTRUMENT. THE CUSTOMER HAD REPORTED SMOKE. THE CUSTOMER ALSO COMMUNICATED TO THE FSE THAT THE SMOKE WAS VISIBLE. THE FSE STATED THAT THERE MIGHT HAVE BEEN LIQUID SPILLED ON THE CORD AND THAT HAD CAUSED SMOKE. HE SEES NO PROBLEM WITH THE INSTRUMENT AND DID NOT FIND ANY BURNT PARTS. THE FSE INSPECTED THE CORD AND THERE WAS NO CORD DAMAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 U0707 TINA SINGLE PUMP NIBPLCD 78FKP FKP BAXTER HEALTHCARE

    Patients

    Seq Age Sex Outcome Treatment
    1