BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOLFLOW® IRRIGATION PUMP

    MDR report key: 2970799 · Received February 20, 2013

    Report

    Report Number
    1721752-2013-00002
    Event Type
    Malfunction
    Date Received
    February 20, 2013
    Date of Event
    January 24, 2013
    Report Date
    January 24, 2013
    Manufacturer
    HEI, INC.
    Product Code
    DRF
    PMA / PMN Number
    P990071/S5
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL IN PROGRESS. A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA ONCE THAT THE REPAIR RECORD IS COMPLETED. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). IT WAS REPORTED THAT INTRA-OP OF AN AVNRT PROCEDURE, AFTER ABLATION THE FLOW RATE FROM THE COOLFLOW PUMP WAS NOT GOING DOWN. IT REMAINS ON 20 ML/MIN. IT WAS ALSO REPORTED THAT ERROR CODE 258 WAS SHOWN BUT ACCORDING TO THE USER MANUAL OF THE PUMP THIS ERROR DOES NOT EXIST. THE PUMP NEEDS TO BE CHECKED. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE CASE, IT WAS STATED THAT THE ISSUE WAS NOTICED BY THE PHYSICIAN VISUALLY AND LATER ON BY THE ERROR MESSAGE. ACCORDING TO THE PHYSICIAN IT WAS CONSIDERED A RISK TO THE PATIENT IF THEY APPLY TOO MUCH FLUID TO THE PATIENT SINCE THE PUMP DID NOT AUTOMATICALLY TURNED DOWN TO 2 ML/MIN AFTER ABLATION. THE PROBLEM WAS SOLVED BY SWITCHING THE PUMP OFF AND ON. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES. AFTER UNIT EVALUATION IT WAS DETERMINED THAT THE PCBA INTERFACE WAS DEFECTIVE. THE ISSUE WAS RESOLVED AFTER PCBA INTERFACE REPLACEMENT. UNIT PASSED FUNCTIONAL AND SAFETY TEST. PM WAS ALSO PERFORMED. THE DEVICE HISTORY RECORD FOR COOL FLOW PUMP SERIAL NUMBER (B)(4) SHOWS THAT NO MANUFACTURING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE RELATED TO FUNCTIONALITY OF THE DEVICE. THE DEVICE MET ALL REQUIREMENTS PRIOR TO DISTRIBUTION. CUSTOMER COMPLAINT WAS CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT INTRA-OP OF AN AVNRT PROCEDURE, AFTER ABLATION THE FLOW RATE FROM THE COOLFLOW PUMP WAS NOT GOING DOWN. IT REMAINS ON 20 ML/MIN. IT WAS ALSO REPORTED THAT ERROR CODE 258 WAS SHOWN BUT ACCORDING TO THE USER MANUAL OF THE PUMP THIS ERROR DOES NOT EXIST. THE PUMP NEEDS TO BE CHECKED. AFTER FOLLOW UP WITH THE CUSTOMER TO OBTAIN DETAILED INFORMATION REGARDING THE CASE, IT WAS STATED THAT THE ISSUE WAS NOTICED BY THE PHYSICIAN VISUALLY AND LATER ON BY THE ERROR MESSAGE. ACCORDING TO THE PHYSICIAN IT WAS CONSIDERED A RISK TO THE PATIENT IF THEY APPLY TOO MUCH FLUID TO THE PATIENT SINCE THE PUMP DID NOT AUTOMATICALLY TURNED DOWN TO 2 ML/MIN AFTER ABLATION. THE PROBLEM WAS SOLVED BY SWITCHING THE PUMP OFF AND ON. THE CASE WAS COMPLETED WITHOUT PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    74860 COOLFLOW® IRRIGATION PUMP PUMP, CIRCULATING-FLUID, LOCALIZED HEAT DRF HEI, INC. M-5491-01

    Patients

    Seq Age Sex Outcome Treatment
    1