BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 13609184 · Received February 26, 2022

    Report

    Report Number
    3010617000-2022-00192
    Event Type
    Malfunction
    Date Received
    February 26, 2022
    Date of Event
    January 15, 2022
    Report Date
    February 25, 2022
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075237
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CATHETER INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT. THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    THE CATHETER INVOLVED IN THE REPORTED COMPLAINT WILL NOT BE RETURNED FOR INVESTIGATION BECAUSE THE CUSTOMER HAS DISPOSED OF IT. THEREFORE, A PHYSICAL INVESTIGATION COULD NOT BE PERFORMED, AND THE ROOT CAUSE COULD NOT BE DETERMINED.

    Description of Event or Problem · 0

    THE START-UP KIT (SUK) (LOT #172206) WAS CONNECTED TO THE THERMOGARD XP IVTM SYSTEM, AND PRIMING WAS PERFORMED TO INITIATE THE IVTM THERAPY FOR A (B)(6)-YEAR-OLD FEMALE PATIENT (WEIGHT - (B)(6) LBS.). AN ICY CATHETER (LOT #UNKNOWN) WAS USED FOR THE IVTM THERAPY. AFTER AN UNKNOWN PERIOD, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) GENERATED AN AIR TRAP ALARM, AND MANY AIR BUBBLES WERE NOTED IN THE SUK AIR TRAP. THE USER OBSERVED AN EMPTY SALINE BAG AND BLOOD TINGE ON THE SUK TUBING, INDICATING A POTENTIAL CATHETER LEAK. THE CUSTOMER DISCARDED THE CATHETER AND THE SUK. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. FOR THE ABOVE-REPORTED EVENT, ZOLL RECEIVED MEDWATCH REPORT # (B)(4) ON (B)(6) 2022. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00241 FOR THE THERMOGARD XP IVTM SYSTEM.

    Description of Event or Problem · 0

    THE START-UP KIT (SUK) (LOT #172206) WAS CONNECTED TO THE THERMOGARD XP IVTM SYSTEM, AND PRIMING WAS PERFORMED TO INITIATE THE IVTM THERAPY FOR A (B)(6)-YEAR-OLD FEMALE PATIENT (WEIGHT - (B)(6)). AN ICY CATHETER (LOT #UNKNOWN) WAS USED FOR THE IVTM THERAPY. AFTER AN UNKNOWN PERIOD, THE THERMOGARD XP IVTM SYSTEM (SN UNKNOWN) GENERATED AN AIR TRAP ALARM, AND MANY AIR BUBBLES WERE NOTED IN THE SUK AIR TRAP. THE USER OBSERVED AN EMPTY SALINE BAG AND BLOOD TINGE ON THE SUK TUBING, INDICATING A POTENTIAL CATHETER LEAK. THE CUSTOMER DISCARDED THE CATHETER AND THE SUK. NO CONSEQUENCES OR IMPACT TO THE PATIENT. THE CUSTOMER PROVIDED NO FURTHER INFORMATION. FOR THE ABOVE-REPORTED EVENT, ZOLL RECEIVED MEDWATCH REPORT # (B)(4) ON (B)(6) 2022. PLEASE SEE THE FOLLOWING RELATED MFR REPORT: MFR 3010617000-2022-00241 FOR THE THERMOGARD XP IVTM SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2358455 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 UNKNOWN 00849111075237

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female