BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC KIT: 3-LUMEN 7 FR X 20 CM

    MDR report key: 1143667 · Received August 29, 2008

    Report

    Report Number
    2518433-2008-00022
    Event Type
    Injury
    Date Received
    August 29, 2008
    Date of Event
    August 10, 2008
    Report Date
    August 29, 2008
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQO
    PMA / PMN Number
    K900263
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS EVENT INVOLVED A MALE PATIENT, WITH NO KNOWN ALLERGIES. HE WAS ADMITTED TO THE HOSPITAL TO UNDERGO PROSTATE SURGERY. PATIENT (PT) WAS TO BE TREATED WITH AN ARROWG+ARD CATHETER DURING PROCEDURE. IN 2008, CATHETER WAS INSERTED VIA INTERNAL JUGULAR APPROACH. ANAPHYLACTIC SHOCK WAS SUSPECTED AS PT REACTED IMMEDIATELY AFTER CATHETER INSERTION. PRIOR TO INSERTION OF CATHETER SYSTOLIC BLOOD PRESSURE WAS STABLE, BETWEEN 130 & 140. ABOUT 3-5 MINUTES AFTER PRESSURE FELL TO 40. MD TRIED TO STABILIZE PT BY USING CATECHOLAMINE (UNKNOWN QTY.). MINUTES AFTER CATHETER INSERTION PT. SHOWED REDNESS ON THE BREAST & BELLY AREAS. APPROXIMATELY 15 MINUTES LATER THERE WERE WELTS ON BREAST & BELLY AREAS. AN APPLICATION OF 1 MG CORTISONE WAS GIVEN TO PT APPROXIMATELY 30 MINUTES AFTER APPLICATION CATHETER WAS REMOVED & REPLACED BY A STANDARD CATHETER. DETAILS OF EVENT: PATIENT (PT) STABILIZED & WAS MOVED TO INTENSIVE CARE STATION FOR FURTHER MONITORING. PT. WAS TO LEAVE HOSPITAL AFTER TWO DAYS FOR FURTHER TREATMENT BY HIS FAMILY PHYSICIAN. THERE HE RECEIVE ALLERGY TESTS FOR CHLORHEXIDINE & SILVER SULFADIAZINE. PT.WILL RETURN TO HOSPITAL IN TWO WEEKS. IF POSSIBLE HOSPITAL WE WILL RECEIVE RESULTS OF ALLERGY TESTS. SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC KIT: 3-LUMEN 7 FR X 20 CM ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC ZF8048602

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention CORTISONE| CATECHOLAMINE