BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COOL POINT¿ IRRIGATION PUMP PRESSURE ALARM ADAPTER CABLE

    MDR report key: 15794887 · Received November 14, 2022

    Report

    Report Number
    2030404-2022-00070
    Event Type
    Malfunction
    Date Received
    November 14, 2022
    Date of Event
    October 26, 2022
    Report Date
    January 13, 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

    ADDITIONAL INFORMATION: G3, H2, H3 THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED ERROR MESSAGE AND SUBSEQUENT DELAY REMAINS UNKNOWN.

    Description of Event or Problem · 0

    RELATED MANUFACTURING REF: 2030404-2022-00068 AND 2030404-2022-00069. 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
    1199005 COOL POINT¿ IRRIGATION PUMP PRESSURE ALARM ADAPTER CABLE CARDIAC ABLATION PERCUTANEOUS CATHETER OAD ST. JUDE MEDICAL H701666

    Patients

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