BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1620465 · Received March 3, 2010

    Report

    Report Number
    6000001-2010-00254
    Event Type
    Malfunction
    Date Received
    March 3, 2010
    Date of Event
    February 1, 2010
    Report Date
    February 8, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RECEIVED FOR EVALUATION. A FOLLOW UP REPORT WILL BE FILED UPON COMPLETION OF THE EVALUATION OR IF ANY ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4)

    Additional Manufacturer Narrative · 1

    THERE IS AN ONGOING CAPA INVESTIGATION, (B)(4) ASSOCIATED WITH THIS REPORT. PATIENT IDENTIFIER A HAS BEEN PROVIDED. (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) IN REGARDS TO REPRODUCIBLE ACCUTNI RESULTS ABOVE THE ACUTE MYOCARDIAL INFARCTION (AMI) CUT-OFF GENERATED BY THE ACCESS 2 IMMUNOASSAY ANALYZER THAT DID NOT MATCH THE PATIENT'S CLINICAL PICTURE. THE SAMPLE WAS REPEATED ON AN ALTERNATE METHOD AND THE RESULTS WERE WITHIN THE NORMAL REFERENCE RANGE. THE RESULT WAS REPORTED OUT OF THE LABORATORY. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    ON FEBRUARY 8, 2010, THE FACILITY'S REPRESENTATIVE ORIGINALLY REPORTED TO BAXTER GLOBAL TECHNICAL SERVICES ONE COLLEAGUE INFUSION PUMP THAT WAS BEEPING LOW BATTERY WHEN NOT PLUGGED IN. AFTER BEING PLUGGED IN, A "TAKE OUT OF SERVICE" MESSAGE WAS DISPLAYED. THIS CONDITION WAS REPORTED TO HAVE HAPPENED DURING PATIENT THERAPY. IN A FOLLOW-UP PHONE CALL, THE FACILITY REPRESENTATIVE REFERRED TO NOTES TO CORRECTLY CLARIFY THE REPORTED CONDITION. THE FACILITY REPRESENTATIVE STATED THAT THE DEVICE WAS INFUSING WHILE PLUGGED IN WHEN THERE WAS AN AUDIBLE ALARM HEARD BY 3 NURSES FROM OUTSIDE OF THE PATIENT'S ROOM. THE NURSES ENTERED THE ROOM TO FIND THAT THE INFUSION HAD STOPPED AND THE PUMP DISPLAYED THE MESSAGE "DAMAGED BATTERY". THE NURSES TOOK THE DEVICE OUT OF SERVICE, HOWEVER, THERE NEVER WAS A MESSAGE THAT STATED "TAKE OUT OF SERVICE", WHICH WAS ORIGINALLY REPORTED. THE FACILITY REPRESENTATIVE STATED THAT AN IV SOLUTION FOR DEHYDRATION WAS BEING INFUSED AND THAT THERE WERE NO REPORTS OF PATIENT INJURY OR MEDICAL INTERVENTION. THE PATIENT WAS REPORTED AS BEING FINE AFTER THE REPORTED CONDITION. THE PUMP WAS SWAPPED OUT FOR A DIFFERENT ONE. NO ADDITIONAL INFORMATION IS AVAILABLE. THE SOFTWARE VERSION FOR THIS DEVICE IS CURRENTLY NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1