BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL POINT¿ IRRIGATION PUMP TUBING SET

    MDR report key: 15794899 · Received November 14, 2022

    Report

    Report Number
    2030404-2022-00068
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 25, 2023
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    OAD
    PMA / PMN Number
    P060019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ONE COOL POINT TUBING SET WAS RECEIVED FOR EVALUATION. FURTHER INVESTIGATION CONCLUDED THAT THE TUBING WAS ABLE TO BE PRIMED AND UNDERWENT FLOW TESTING WITH NO ERROR MESSAGES NOTED. THE DEVICE WAS MANUFACTURED ACCORDING TO SPECIFICATIONS AS SUPPORTED BY THE RECEIVING INSPECTION RESULTS. THE CAUSE OF THE REPORTED LEAK REMAINS UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 2030404-2022-00069 AND 2030404-2022-00070. DURING THE ATRIAL TACHYCARDIA ABLATION, THERE WAS A PROCEDURE DELAY DUE TO PRESSURE AND BUBBLE ERRORS DUE TO THE PRESSURE ADAPTOR CABLE AND TWO TUBING SETS. WHILE PREPPING THE COOL POINT PUMP TUBING FOR THE TACTICATH SE THERE WAS A REPEATING PRESSURE ERROR ONCE THE CATHETER WAS HOOKED UP. THE TUBING HAD ALREADY BEEN FLUSHED ON 60 ML/MIN AND HAD RUN WITHOUT ISSUE. THE CATHETER WAS THEN DISCONNECTED AND IT WAS ATTEMPTED TO FLUSH IT, BUT THE PRESSURE ERROR REOCCURRED. THE COOL POINT PUMP WAS TURNED OFF AND ON AND RECONNECTED TO THE TUBING MULTIPLE TIMES. ONCE THE PRESSURE ADAPTOR CABLE WAS REPLACED THE PRESSURE ERROR WENT AWAY. THE PUMP RAN AT 60, BUT INSTEAD WAS GIVING THE BUBD ERROR WHEN ATTEMPTING TO RUN AT 2ML/MIN. NO BUBBLES WERE OBSERVED SO A NEW TUBING SET WAS EXCHANGED, BUT THE BUBD ERROR DID NOT RESOLVE. A LEAK WAS NOTICED WITHIN THE TWIST CONNECTION OF THE TUBING AND DESPITE TIGHTENING THE LEAK DID NOT STOP. A THIRD TUBING SET WAS USED AND THERE WERE NO FURTHER ISSUES. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO ADVERSE CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262612 COOL POINT¿ IRRIGATION PUMP TUBING SET CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER OAD ST. JUDE MEDICAL 85785 H2448339

    Patients

    Seq Age Sex Outcome Treatment
    1 Female COOL POINT¿ IRRIGATION PUMP PRESSURE CABLE.| COOL POINT¿ IRRIGATION PUMP TUBING SET.