BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARTERIAL CATH SET: 18GA X 8CM

    MDR report key: 1725453 · Received June 11, 2010

    Report

    Report Number
    3006425876-2010-00039
    Event Type
    Death
    Date Received
    June 11, 2010
    Date of Event
    May 18, 2010
    Report Date
    June 4, 2010
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQO
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT NORADRENALINE WAS BEING ADMINISTERED TO THE PT VIA RIGHT RADIAL INSERTION SITE. THREE DAYS AFTER THE CATHETER WAS INSERTED, THE USER WAS UNABLE TO WITHDRAW BLOOD AND A BLOCKED CATHETER WAS SUSPECTED. AS A RESULT, THE PHYSICIAN INSERTED A NEW CATHETER VIA LEFT RADIAL SITE. THE NURSE REPORTED THAT THE PT HAD A HEART ATTACK THAT SAME MORNING, BUT IS FEELING GOOD. SHE COULD NOT CONFIRM THAT THE TWO ISSUES WERE RELATED. ADDITIONAL REPORTED INFO STATED THAT THIS USER DOES NOT USE HEPARIN. FURTHER ADDITIONAL INFO RECEIVED ON 06/03/2010 FROM THE UNIT MGR STATED THAT THERE WAS NO RELATION BETWEEN THE INCIDENT AND THE HEART ATTACK. TO DATE, THE PT IS DECEASED, BUT THERE IS NO RELATION BETWEEN HIS DEATH AND THE DEVICE. THE DEVICE WAS NOT REMOVED. A FEW TIMES AFTER THIS PROBLEM, THE DEVICE BEGAN TO WORK (NO INFO ON HOW LONG AFTER THE PROBLEM). THE DEVICE WAS REMOVED APPROXIMATELY 7 DAYS AFTER THE INSERTION, IS HOW IT IS MENTIONED IN THEIR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATH SET: 18GA X 8CM ARTERIAL CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC. ZF0023151

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death NORADRENALINE