BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM ICY CATHETER

    MDR report key: 5753847 · Received June 27, 2016

    Report

    Report Number
    3010617000-2016-00446
    Event Type
    Malfunction
    Date Received
    June 27, 2016
    Date of Event
    June 1, 2016
    Report Date
    August 24, 2016
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075084
    PMA / PMN Number
    K101987
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ZOLL HAS NOT YET RECEIVED THE ZOLL CATHETER IN COMPLAINT FOR INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE FILED IF AND WHEN THE PRODUCT IS RETURNED AND INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    AN ICY CATHETER (S/N (B)(4)) WAS RETURNED TO ZOLL (B)(4) FOR EVALUATION. A VISUAL INSPECTION FOUND NO VISUAL DISCREPANCIES OR ISSUES. ALL LUMENS FLUSHED AS INTENDED. NO LEAKS WERE NOTICED DURING FLUSHING. THE RETURNED CATHETER WAS CONNECTED TO A PRESSURIZED INFLATION DEVICE. THE DEVICE WAS PRESSURIZE UP TO 100PSI, AND A LEAK PATH WAS IDENTIFIED AT THE BOND NEAR PROXIMAL END OF THE MEDIAL BALLOON. EVALUATION OF THE RETURNED DEVICES CONFIRMED THE CUSTOMER REPORTED ISSUE AS AN ICY CATHETER LEAKED AT THE BONDING NEAR PROXIMAL END OF THE MEDIAL BALLOON. PROBABLE CAUSES FOR THE REPORTED COMPLAINT WERE A LATENT DEFORMITY IN THE BOND, WHICH RESULTED IN EVENTUAL LEAK UNDER PRESSURE, OR A BOND DELAMINATION INCURRED DURING CATHETER PLACEMENT. THERE WAS NO PATIENT INJURY OR DEATH ATTRIBUTABLE TO THE CATHETER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 2 DAYS AFTER THE ICY CATHETER WAS INSERTED IN A PATIENT, BLOOD WAS NOTICED IN THE TEAL OUT FLOW LUMEN OF THE ICY CATHETER. SALINE WAS BEING SLOWLY LOST. NURSE CONNECTED A SYRINGE TO THE TEAL PORT AND TRIED SOME VACUUM PRESSURE BUT WASN'T ABLE TO WITHDRAW THE BLOOD. AFTER THERAPEUTIC HYPOTHERMIA, NORMO-THERMIA IS NOW BEING MAINTAINED. PATIENT IS HAVING SOME FEVERS. OTHER METHODS ARE BEING USED TO CONTROL THE TEMPERATURE. NO HARM TO PATIENT HAS BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406509 ZOLL IVTM ICY CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-3893 59253 00849111075084

    Patients

    Seq Age Sex Outcome Treatment
    1