BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOLFLOW® IRRIGATION PUMP

    MDR report key: 2091949 · Received May 18, 2011

    Report

    Report Number
    1721752-2011-00004
    Event Type
    Injury
    Date Received
    May 18, 2011
    Date of Event
    March 8, 2011
    Report Date
    March 30, 2011
    Manufacturer
    HEI, INC.
    Product Code
    DRF
    PMA / PMN Number
    P990071/S5
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE UNIT WAS SENT TO THE REPAIR FACILITY FOR PREVENTATIVE MEASURES WHERE THE UNIT WAS TESTED FOR SAFETY AND FUNCTIONALITY AND WAS FOUND ACCEPTABLE. UNIT COMPLETED CALIBRATION PROCEDURE AND COOL FLOW PUMP FINAL TEST PROCEDURE WITHOUT ANY ISSUES, UNIT MET ALL REQUIREMENTS. THE DEVICE HISTORY RECORD FOR COOLFLOW PUMP (B)(4) SHOWS THAT NO REPROCESSING OR TEST FAILS WERE NOTED DURING THE MANUFACTURING CYCLE. THE DEVICE PASSED FINAL TEST AND MET ALL SPECIFIED REQUIREMENTS PRIOR TO DISTRIBUTION.

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS ADMITTED TO ICU FOR 4 DAYS AND THEN DISCHARGED. NO FURTHER INFORMATION ABOUT THE PRODUCT OR THE PROCEDURE HAS BEEN PROVIDED BY THE CUSTOMER. THE CUSTOMER REQUESTED SERVICE FOR THE EQUIPMENT AS A PREVENTATIVE MEASURE ON (B)(6) 2011 AS THERE WAS NO MALFUNCTION OCCURRED AT THE TIME OF THE EVENT PER THE CUSTOMER. ONCE THE SERVICE HAS BEEN COMPLETED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA AS REQUIRED. CONCOMITANT PRODUCTS: CARTO 3 SYSTEM, CATALOG # M480001, (B)(4). STOCKERT 70 RF GENERATOR, CATALOG # S7001, (B)(4). SOUNDSTAR, CATALOG # UNKNOWN, LOT # UNKNOWN. EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER, CATALOG # BNI75TCDFH, LOT # UNKNOWN (MANUFACTURER REPORT # 2029046-2011-00026). (B)(4).

    Description of Event or Problem · 1

    DURING AN ATRIAL FIBRILLATION PROCEDURE, IT WAS REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED AND AN ULTRASOUND CONFIRMED PERICARDIAL EFFUSION. A PERICARDIOCENTESIS WAS PERFORMED. THE STATUS OF THE PATIENT WAS UNKNOWN AT THE TIME OF THE CALL. THE PHYSICIAN STATED THAT A STEAM POP HAD OCCURRED RIGHT BEFORE THE PERICARDIAL EFFUSION. BOTH THE CATHETERS INVOLVED IN THE PROCEDURE WERE DISPOSED BY THE CUSTOMER POST PROCEDURE. THIS PRODUCT HAS PREVIOUSLY BEEN REPORTED AS A CONCOMITANT PRODUCT UNDER MANUFACTURER REPORT # 2029046-2011-00026. BIOSENSE WEBSTER RECEIVED A REQUEST FROM THE CUSTOMER TO SERVICE THIS EQUIPMENT AS A PRECAUTION ON (B)(6) 2011 (A.E. ALERT DATE) AND THEREFORE, WE ARE REPORTING THIS PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOLFLOW® IRRIGATION PUMP PUMP, CIRCULATING-FLUID, LOCALIZED HEAT DRF HEI, INC. M-5491-02

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R