BEUDAMED
    FDA Adverse Event Death Summary report: N

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS

    MDR report key: 2193009 · Received July 29, 2011

    Report

    Report Number
    1820334-2011-00394
    Event Type
    Death
    Date Received
    July 29, 2011
    Report Date
    June 29, 2011
    Manufacturer
    COOK, INC.
    Product Code
    FOZ
    PMA / PMN Number
    K060174
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF DEATH IS UNKNOWN. INFORMATION WAS NOT PROVIDED BY THE REPORTER. COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS CATHETER SET. CATALOG #: C-UQLM-1001J-LSC-WCE-ABRM-HC-RD. EXPIRATION DATE UNKNOWN AS LOT IS UNKNOWN. (B)(4). DEATH IS ADDRESSED IN THE IFU. EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED STATED THAT THE SPECTRUM CATHETERS WERE REMOVED FROM PATIENT. AFTER 0.5 HRS, THE PATIENT SEEMED TO GET INTO LITTLE SHOCK SYMPTOMS AND SEEM TO HAVE SMALL CONVULSIONS. ONE OF THE DOCTORS ASKED IF THE REASON COULD BE AN AIR EMBOLISM. THE WHOLE TEAM DECIDED THAT AN AIR EMBOLISM IS NORMALLY NOT OCCURRING AFTER REMOVING A CVC. (1820334-2011-00395). ONE PATIENT EXPIRED (WHEN IS UNKNOWN YET). AUTOPSY REVEALED NO SIGNS FOR AIR EMBOLISM AND THE CATHETER HAD NO INFECTION SIGNS. ATTEMPTS ARE BEING MADE TO RECEIVE ADDITIONAL INFORMATION AND CLARIFICATION OF THE REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death