BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALINDROME EMERALD 23/40KIT VT

    MDR report key: 2076577 · Received April 25, 2011

    Report

    Report Number
    1317749-2011-00139
    Event Type
    Other
    Date Received
    April 25, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 12, 2011
    Manufacturer
    COVIDIEN
    Product Code
    NYU
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE: 04/25/2011. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2011 THAT A CUSTOMER HAD AN ISSUE WITH A HEMODIALYSIS CATHETER. THE CUSTOMER REPORTS A PATIENT GOT HIT II (HEPARIN INDUCED THROMBOSIS AND THROMBOCYTOPENIA) FROM A PALINDROME H (HEPARIN COATED) CATHETER. CATHETER WAS INSERTED ON (B)(6) 2011 AND THERE WAS NO ABILITY TO DEVELOP HIT II BY PATIENT HISTORY. NO LAB TESTS AVAILABLE. THEY HAVE EXCHANGED THE CATHETER TO A NON COATED ONE. A SECOND HEPARIN SOURCE REGARDING THIS PATIENT WAS CLIXANE. THE CATHETER HAS BEEN EXCHANGED FOR ANALYSIS AND PATIENT SAFETY. ADDITIONAL INFORMATION RECEIVED THAT PATIENT WAS GIVEN A PRIMING SOLUTION: TAUROLOCK ON HEPARIN BASED ADMINISTRATION TWO TIMES HEPARIN THAN CHANGE TO CLEXANE (NMH). OPERATION IN AN OTHER HOSPITAL FOR STENT IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALINDROME EMERALD 23/40KIT VT HEMODIALYSIS CATHETER NYU COVIDIEN 8888145044 026010

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention