BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ABG-HM-1; HUMMI MICRO DRAW BLOOD TRANSFER DEVI

    MDR report key: 4366749 · Received August 4, 2014

    Report

    Report Number
    3009382876-2014-00001
    Event Type
    Injury
    Date Received
    August 4, 2014
    Date of Event
    July 22, 2014
    Report Date
    August 4, 2014
    Manufacturer
    HUMMINGBIRD MED
    Product Code
    KST
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    HUMMINGBIRD MED SIMULATION TEST INDICATES USER ERROR (NOT FOLLOWING IFU AND IN-SERVICE TRAINING) BY INSERTING THE HUMMI DEVICE INAPPROPRIATELY INTO THE PERIMETER OF THE SEPTUM. IMPROPER INSERTION OF ANY BLUNT CANNULA MAY DEFORM THE SEPTUM AND ALLOW FLUIDS TO LEAK OUT BETWEEN THE SEPTUM AND SIDEWALL OF THE DEVICE. DIRECT COMMUNICATION WITH THE REPORTING NURSE AT THE HOSPITAL INDICATED THE HOSPITAL HAS STOPPED USING HUMMI PRODUCT UNTIL AN APPROPRIATE T-CONNECTOR FROM ANOTHER SUPPLIER IS AVAILABLE. CONTACT NURSE COULD NOT SUPPLY FURTHER INFO. THE FAILURE OF THE T-CONNECTOR WAS REPORTED BY THE NURSE TO BAXTER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BAXTER T-CONNECTOR HAD LEAKED, AFTER BEING USED TO ACCESS ARTERIAL BLOOD FROM A BABY WITH THE ABG-HM-1 (HUMMI). THE NURSE STATED THAT THE BABY LOST 8ML OF BLOOD AND REQUIRED A BLOOD TRANSFUSION DUE TO THE BLOOD LOSS, SINCE IT HAD OCCURRED ON A LOW BIRTH WEIGHT BABY. THE NURSE MENTIONED THAT THE SEPTUM HAD THE APPEARANCE OF BEING SOMEWHAT "PUSHED IN."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455637 ABG-HM-1; HUMMI MICRO DRAW BLOOD TRANSFER DEVI SYSTEM, BLOOD COLLECTION, VACUUM-ASS KST HUMMINGBIRD MED ABG-HM-1 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention