BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLFLOW® IRRIGATION PUMP

    MDR report key: 1960007 · Received January 13, 2011

    Report

    Report Number
    1721752-2011-00001
    Event Type
    Malfunction
    Date Received
    January 13, 2011
    Date of Event
    December 21, 2010
    Report Date
    January 4, 2011
    Manufacturer
    HEI, INC.
    Product Code
    DRF
    PMA / PMN Number
    P990071/S5
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT AN R1 ERROR (ROTATION VELOCITY ERROR) APPEARED ON THE PUMP AFTER A FEW SECONDS OF DELIVERING FLUID. THE PUMP WAS RETURNED TO OCD FOR ANALYSIS. THE ENCODER BASE PLATE WAS FIXED. AFTER REPAIR, PREVENTIVE MAINTENANCE, SAFETY AND FULL FUNCTIONAL TESTS WERE PERFORMED AND PASSED. THE DEVICE HISTORY RECORD FOR COOLFLOW PUMP SERIAL NUMBER (B)(4) SHOWS THAT NO REPROCESSING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO THE STATED PROBLEM OF AN R1 ROTATION VELOCITY ERROR.

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION IS STILL IN PROGRESS AND A SUPPLEMENTAL WILL BE SUBMITTED ONCE IT IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT R1 ERROR (ROTATION VELOCITY ERROR) APPEARED ON PUMP AFTER A FEW SECONDS OF DELIVERING FLUID. THE ERROR R1 WAS DETECTED WHEN THE NURSES TRIED TO START THE PUMP. LATER, THE EP LAB PERSONNEL ALSO TRIED TO STRENGTHEN THE SCREWS, CHANGED THE TUBING SET, BUT THE ERROR DID NOT DISAPPEAR. THE PATIENT WAS IN FULL ANAESTHESIA. THERE WAS NO DIRECT HARM TO THE PATIENT BECAUSE OF THIS ERROR,AS ABLATION WAS DISABLED, BUT THE PROCEDURE COULD NOT BE PROCEEDED AND WAS RESCHEDULED TO A LATER DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLFLOW® IRRIGATION PUMP PUMP, CIRCULATING-FLUID, LOCALIZED HEAT DRF HEI, INC. M-5491-01

    Patients

    Seq Age Sex Outcome Treatment
    1