BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1910132 · Received November 30, 2010

    Report

    Report Number
    6000001-2010-05323
    Event Type
    Malfunction
    Date Received
    November 30, 2010
    Date of Event
    September 29, 2010
    Report Date
    October 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Removal / Correction Number
    6000001-3/15/05-007-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THIS DEVICE WAS RETURNED TO BAXTER FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED. THE REPORTED CONDITION OF A PUMP FAILURE WAS CONFIRMED. THE ROOT CAUSE WAS NOT IDENTIFIED. NO FURTHER TESTING HAS BEEN COMPLETED AT THIS TIME AND NO REPAIRS HAVE BEEN PERFORMED AS THE REFERENCED DEVICE HAS BEEN REMOVED FROM SERVICE. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THE REPORTED CONDITION OCCURRED ON (B)(6), 2010 AND NOT THE ORIGINALLY REPORTED OCCURRENCE DATE OF (B)(6), 2010. CORRECTED INFORMATION: THE REPORTED CONDITION WAS CONFIRMED AS FAILURE CODE 810:11, WHICH INTERRUPTED DELIVERY. THIS INFORMATION WAS ERRONEOUSLY EXCLUDED FROM THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE HAS NOT BEEN PREVIOUSLY SENT INTO SERVICE FOR THE REPORTED CONDITION OF 'PUMP FAILURE.' BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ONE (1) INFUSOR SV 2 DEVICE WAS OBSERVED LEAKING AT THE CONNECTION OF THE BLUE WINGED CAP AND LUER LOCK AFTER FILLING. THE DEVICE WAS FILLED WITH 5-FLUOROURACIL AND NORMAL SALINE. THERE IS NO PATIENT INVOLVEMENT; THEREFORE, NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A COLLEAGUE INFUSION PUMP WHICH EXPERIENCED A PUMP FAILURE. IT IS UNKNOWN WHEN OR AT WHAT POINT IN THE PROCESS THE REPORTED CONDITION OCCURED. REVIEW OF THE DEVICE EVENT HISTORY DETERMINED THAT THIS CONDITION INTERRUPTED DELIVERY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THIS DEVICE IS A REMEDIATED COLLEAGUE PUMP WITH A USER INTERFACE MODULE SOFTWARE VERSION OF 5.09.90. NO ADDITIONAL INFORMATION IS AVAILABLE.

    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