BEUDAMED
    FDA Adverse Event Death Summary report: N

    3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS

    MDR report key: 5518037 · Received March 22, 2016

    Report

    Report Number
    2110898-2016-00041
    Event Type
    Death
    Date Received
    March 22, 2016
    Date of Event
    February 18, 2016
    Report Date
    February 26, 2016
    Manufacturer
    3M HEALTH CARE
    Product Code
    LKB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFUSION NURSES SOCIETY (INS) IS A GLOBALLY RECOGNIZED AUTHORITY FOR BEST PRACTICES RELATED TO INFUSION THERAPY. IN THE FIFTH EDITION OF INFUSION NURSES SOCIETY (INS) POLICIES AND PROCEDURES, IT STATES THE FOLLOWING UNDER KEY POINTS RELATED TO AIR EMBOLISM: ENSURE THE VASCULAR ACCESS DEVICE (VAD) IS SECURELY CLAMPED WHEN DISCONNECTING/RECONNECTING A NEW ADMINISTRATION SET, NEEDLELESS CONNECTOR, OR ANY OTHER ADD-ON DEVICE. THE CENTRAL VASCULAR ACCESS DEVICE WAS NOT CLAMPED WHEN THE IV WAS DISCONNECTED. IN ADDITION, THE CUROS DISINFECTING PORT PROTECTOR WAS NOT USED AS DIRECTED. PRODUCT PACKAGING CONTAINS DIRECTIONS FOR USE AND INTENDED USE INFORMATION. INTENDED USE: THE CUROS IS INTENDED FOR USE ON SWABBABLE LUER ACCESS VALVES AS A DISINFECTING CLEANER PRIOR TO LINE ACCESS AND TO ACT AS A PHYSICAL BARRIER TO CONTAMINATION BETWEEN LINE ACCESSES.

    Description of Event or Problem · 1

    CUSTOMER REPORTED A FEMALE PATIENT WITH AN ABSCESS/BOWEL PERFORATION WAS RECEIVING ANTIBIOTICS THROUGH AN INTERNAL JUGULAR, TRIPLE LUMEN CENTRAL LINE CATHETER. A NURSING STUDENT REPORTEDLY DISCONNECTED THE IV SETUP (SALINE BAG/ANTIBIOTIC PIGGY BACK AND NEEDLELESS CONNECTOR) DOWN TO THE CATHETER HUB. CUSTOMER REPORTED THE CENTRAL LINE CATHETER LUMEN WAS NOT CLAMPED WHEN THE IV WAS DISCONNECTED AND A CUROS CAP WAS PLACED DIRECTLY ON THE CENTRAL LINE CATHETER HUB. AFTER DISCONNECTING THE IV, THE PATIENT WAS MOVED TO A CHAIR. CUSTOMER STATED THE PATIENT THEN EXPERIENCED HEADACHES AND RESPIRATORY ISSUES WHICH LED TO A RESPIRATORY ARREST. CUSTOMER REPORTED PATIENT WAS IN SERIOUS CONDITION, DIAGNOSED WITH A MASSIVE AIR EMBOLIC STROKE AND DIED SIXTEEN DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173793 3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS 3M CUROS DISINFECTING CAP FOR NEEDLELESS CONNECTORS LKB 3M HEALTH CARE

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Death