BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COOK SPECTRUM MINOCYCLINE/RIFAMPIN IMPREGNATED FIVE LUMEN CENTRAL VENOUS

    MDR report key: 2193341 · Received July 29, 2011

    Report

    Report Number
    1820334-2011-00395
    Event Type
    Injury
    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 Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    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. SOME PATIENTS HAVE HAD INFECTIONS IN THE TISSUE BECAUSE THE CVC WERE DISLOCATED. ONE PATIENT EXPIRED (WHEN IS UNKNOWN YET) AND RECEIVED AN AUTOPSY. THERE WERE NO SIGNS FOR AIR EMBOLISM IN THE AUTOPSY AND THE CATHETER HAD NO INFECTION SIGNS. (1820334-2011-00394), ATTEMPTS ARE BEING MADE TO RECEIVE ADDITIONAL INFORMATION AND CLARIFICATION OF THE REPORT. OUTCOME OF THE PATIENT UNKNOWN AS NOT PROVIDED BY REPORTER.

    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 Other