BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLAVE

    MDR report key: 1900956 · Received October 14, 2010

    Report

    Report Number
    1900956
    Event Type
    Injury
    Date Received
    October 14, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 14, 2010
    Manufacturer
    ICU MEDICAL
    Product Code
    FPA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS A NEWLY ADMITTED POST OPERATIVE CARDIAC PATIENT TO THE PEDIATRIC INTENSIVE CARE UNIT (PICU). THE NURSE RECOGNIZED THE PATIENT WAS HYPOTENSIVE WITH POOR PERFUSION. THE RN RE-ASSESSED THE CENTRAL LINE PRIOR TO GIVING A FLUID BOLUS, AND DISCOVERED THAT SHE WASN'T ABLE TO INSTILL FLUID. THE BED WAS SATURATED WITH FLUID WHICH TURNED OUT TO BE CARDIAC MEDICATION THAT WAS NOT INFUSED BECAUSE OF A CLAVE MALFUNCTION. THE RN REPLACED THE CLAVE, AND THEN WAS ABLE TO FREELY INSTILL THE FLUID BOLUS WITH NO FURTHER LEAKING OF FLUID INTO THE PATIENT'S BED. UPON INSPECTION OF THE REMOVED CLAVE, THE "POP-IT" INTERNAL VALVE PIECE WAS IMPROPERLY DISLOCATED OUTWARD.====================== HEALTH PROFESSIONAL'S IMPRESSION======================STAFF WERE NOT ABLE TO ADMINISTER THE PATIENT'S MEDICATIONS DUE TO THE DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLAVE NEEDLELESS CONNECTOR FPA ICU MEDICAL * 91548-LA & 91244-R5

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other| R CARDIAC DRUGS