BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPROBE 1/4 IN CARMEDA CT

    MDR report key: 3370227 · Received August 20, 2013

    Report

    Report Number
    3370227
    Event Type
    Injury
    Date Received
    August 20, 2013
    Date of Event
    August 8, 2013
    Report Date
    August 19, 2013
    Manufacturer
    MEDTRONIC INC
    Product Code
    NDT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IS A PREMIE BORN (B)(6) 2013 AT (B)(6) GESTATION WITH SEVERE PULMONARY HYPOPLASIA, TRANSFERRED FROM OUTSIDE HOSP FOR NICU CARE AND ECMO (EXTRA CORPOREAL MEMBRANE OXYGENATION.) ONCE ECMO WAS RUNNING, A PART IN THE ECMO CIRCUIT (BIOPROBE) STARTED TO SPRAY BLOOD. ECMO CIRCUIT WAS CLAMPED, PT RECEIVED CPR FOR 1 MINUTE, CRACKED PART REMOVED, ECMO CIRCUIT WAS RECONNECTED WITH A DIFFERENT TYPE CONNECTOR AND THE ECMO WAS RESUMED. TOTAL CLAMP TIME 2 MINUTES. PT HAD NO MEASUREABLE LONG TERM INJURY FROM THE INCIDENT. CRACKED PART WAS SEQUESTERED AND WILL BE RETURNED TO THE MFR FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402071 BIOPROBE 1/4 IN CARMEDA CT NONE NDT MEDTRONIC INC 516491

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Life Threatening| R MEDTRONIC PERFUSION SYSTEM: CAT/VENDOR # CB4627| ECMO CIRCUIT: LOT # 206199886