BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC SET: 2-LUMEN 8 FR X 20 CM

    MDR report key: 7732836 · Received July 30, 2018

    Report

    Report Number
    3006425876-2018-00487
    Event Type
    Injury
    Date Received
    July 30, 2018
    Date of Event
    April 21, 2018
    Report Date
    July 16, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTS: THE PATIENT WAS ADMITTED TO HOSPITAL FOR ESOPHAGECTOMY WITH RECONSTRUCTION AND JEJUNOSTOMY FOR FEEDING. THE OPERATION WAS ARRANGED ON 04/21. AT 0745 ANESTHESIA WAS INDUCED WITH FENTANYL, PROPOFOL AND ROCURONIUM. 0810 2-WAY CVC (ARROWGARD BLUE CATHETER CS-25802E) WAS INSERTED IN THE RIGHT INTERNAL JUGULAR VEIN FOLLOWING SKIN PREPARATION OF 2% CHLORHEXIDINE SOLUTION. 0822 PROGRESSIVE HYPOTENSION AND ERYTHEMATOUS RASH OVER FACE, CHEST AND BOTH HANDS WERE NOTED. CVC WAS REMOVED IMMEDIATELY. EPINEPHRINE AND HYDROCORTISONE IV PUSH WERE GIVEN. 0824 CARDIOPULMONARY CEREBRAL RESUSCITATION WAS STARTED PROMPTLY UNTIL RETURN OF SPONTANEOUS CIRCULATION WAS OBSERVED AT 0905. 0905 ECMO WAS IMPLANTED TO SUPPORT CIRCULATION BECAUSE OF POOR CARDIAC OUTPUT. CHEST ECHO REVEALED NO PLEURAL EFFUSION OR HEMOTHORAX. THE SURGERY WAS ABANDONED, AND THE PATIENT WAS SENT TO INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT.THE PATIENT'S VITAL SIGNS STABILIZED AND REGAINED CONSCIOUSNESS SOON ON THE SAME DAY. THE PATIENT WAS EXTUBATED AND REMOVED FROM ECMO. THE PATIENT RECEIVED CCRT LATER WITH NO SIGNS OF LONG TERM SEQUELAE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: THE PATIENT WAS ADMITTED TO HOSPITAL FOR ESOPHAGECTOMY WITH RECONSTRUCTION AND JEJUNOSTOMY FOR FEEDING. THE OPERATION WAS ARRANGED ON (B)(6). AT 0745 ANESTHESIA WAS INDUCED WITH FENTANYL, PROPOFOL AND ROCURONIUM. AT 0810 2-WAY CVC (ARROWGARD BLUE CATHETER CS-25802E) WAS INSERTED IN THE RIGHT INTERNAL JUGULAR VEIN FOLLOWING SKIN PREPARATION OF 2% CHLORHEXIDINE SOLUTION. AT 0822 PROGRESSIVE HYPOTENSION AND ERYTHEMATOUS RASH OVER FACE, CHEST AND BOTH HANDS WERE NOTED. CVC WAS REMOVED IMMEDIATELY. EPINEPHRINE AND HYDROCORTISONE IV PUSH WERE GIVEN. AT 0824 CARDIOPULMONARY CEREBRAL RESUSCITATION WAS STARTED PROMPTLY UNTIL RETURN OF SPONTANEOUS CIRCULATION WAS OBSERVED AT 0905. AT 0905 ECMO WAS IMPLANTED TO SUPPORT CIRCULATION BECAUSE OF POOR CARDIAC OUTPUT. CHEST ECHO REVEALED NO PLEURAL EFFUSION OR HEMOTHORAX. THE SURGERY WAS ABANDONED, AND THE PATIENT WAS SENT TO INTENSIVE CARE UNIT FOR FURTHER MANAGEMENT. THE PATIENT'S VITAL SIGNS STABILIZED AND REGAINED CONSCIOUSNESS SOON ON THE SAME DAY. THE PATIENT WAS EXTUBATED AND REMOVED FROM ECMO. THE PATIENT RECEIVED CCRT LATER WITH NO SIGNS OF LONG TERM SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    573312 ARROW CVC SET: 2-LUMEN 8 FR X 20 CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL INC. 71F18A0306

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention N/A.