BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 3143173 · Received May 30, 2013

    Report

    Report Number
    3003793491-2013-00647
    Event Type
    Injury
    Date Received
    May 30, 2013
    Report Date
    July 25, 2012
    Manufacturer
    ZOLL CIRCULATION, INC.
    Product Code
    NCX
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CATHETER WILL NOT BE RETURNED TO ZOLL MEDICAL CORPORATION FOR ANALYSIS THEREFORE A SUPPLEMENTAL REPORT WILL NOT BE SUBMITTED. PRODUCT LABELING "INSTRUCTIONS FOR USE" STATES THAT: "POSSIBLE COMPLICATIONS WITH CENTRAL VENOUS CATHETERS INCLUDE: ATRIAL OR VENTRICULAR PERFORATION, CARDIAC TAMPONADE, AIR EMBOLISM, CATHETER EMBOLISM, THORACIC DUCT LACERATION, BACTEREMIA, SEPTICEMIA, THROMBOSIS, INADVERTENT ARTERIAL PUNCTURE, HEMATOMA FORMATION, HEMORRHAGE, NERVE DAMAGE AND DYSRHYTHMIAS". NOTE: FIRST PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00644. SECOND PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00645. THIRD PATIENT IS REPORTED UNDER MFR# 3003793491-2013-00647.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED THAT THEY HAVE HAD 4 AND POSSIBLY A 5TH PATIENT TREATED WITH ZOLL CIRCULATION COOLING CATHETERS RESULT IN DVT (DEEP VEIN THROMBOSIS) IN THE LAST MONTH. THREE OF THESE WERE ICU PATIENTS, OF THIS ONE WITH TRAUMATIC BRAIN INJURY AND ONE WAS A POST CARDIAC ARREST PATIENT. THIS REPORT IS TO ADDRESS THE 4TH AND 5TH PATIENT AS NO OTHER INFORMATION WAS ABLE TO BE PROVIDED. NOTE: ALTHOUGH SPECIFIC INFORMATION WAS NOT PROVIDED, THIS REPORT IS SUBMITTED TO CAPTURE THE REPORTED COMMENT CONCERNING THE 4TH AND 5TH PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238794 UNK UNK NCX ZOLL CIRCULATION, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other