BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EMPTY EVAC CONT 500 ML

    MDR report key: 1760634 · Received July 14, 2010

    Report

    Report Number
    1048698-2010-00001
    Event Type
    Injury
    Date Received
    July 14, 2010
    Date of Event
    June 16, 2010
    Report Date
    June 16, 2010
    Manufacturer
    HOSPIRA, INC.
    Product Code
    KPE
    PMA / PMN Number
    PREAMEN
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO HOSPIRA FOR TESTING AND INVESTIGATION; THEREFORE, ATTRIBUTION OF THE ISSUE TO THE DEVICE COULD NOT BE DETERMINED. THIS REPORT REPRESENTS ALL THE INFORMATION KNOWN BY THE REPORTER UPON QUERY BY HOSPIRA PERSONNEL. (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER CONTACT REPORTED AN ADVERSE EVENT FOLLOWING A LOSS OF VACUUM. A THERAPEUTIC PHLEBOTOMY WAS INITIATED ON THE PATIENT TO REMOVE 500ML OF BLOOD. THE EMPTY GLASS EVACUATED CONTAINER WAS PLACED BELOW THE PATIENT IN THE UPRIGHT POSITION. AFTER AN IV CATHETER INSERTED INTO THE PATIENT, THE EMPTY GLASS EVACUATED CONTAINER WAS SPIKED WITH A 20 GAUGE BUTTERFLY NEEDLE. AFTER APPROXIMATELY 150ML OF BLOOD HAD BEEN COLLECTED, IT WAS REPORTED THAT THE BLOOD STOPPED FLOWING IN THE TUBING SET AND REPORTEDLY THE TUBING "BECAME CLEARER." AIR AND FLUID WAS NOTED TO BE BACKFLOWING TO THE PATIENT. THE PATIENT REPORTED THAT HE "FELT BUBBLES GOING UP HIS ARM." THE NURSE REPORTED CREPITUS ABOVE THE PATIENT'S IV CATHETER INSERTION SITE "AFTER THE CLEAR SECTION OF TUBING WAS NOTED." THE TUBING WAS CLAMPED. A REPLACEMENT EMPTY GLASS EVACUATED CONTAINER WAS OBTAINED AND THE PROCEDURE WAS RESUMED. THE SECOND EMPTY GLASS EVACUATED CONTAINER COLLECTED THE REMAINING 350ML OF BLOOD. THE PATIENT WAS TRANSFERRED TO THE EMERGENCY DEPARTMENT (ED). ON THE WAY TO THE ED, THE PATIENT'S BLOOD PRESSURE DECREASED TO AN UNSPECIFIED LEVEL. IT WAS REPORTED, THE PATIENT BECAME DIAPHORETIC, AND BEGAN TO COMPLAIN OF CHEST PAIN. THE PATIENT UNDERWENT A CT SCAN AND ECHOCARDIOGRAM TO RULE OUT AN AIR EMBOLISM. AFTER AN UNSPECIFIED LENGTH OF TIME, THE PATIENT'S BLOOD PRESSURE RETURNED TO "NORMAL." THE CUSTOMER CONTACT INDICATED THE DIAPHORESIS AND CHEST PAIN RESOLVED WITHOUT ANY MEDICAL INTERVENTION. THE PATIENT WAS ADMITTED OVERNIGHT FOR OBSERVATION, BUT WAS REPORTED TO BE "FINE." THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. THOUGH REQUESTED, NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EMPTY EVAC CONT 500 ML 80KPE KPE HOSPIRA, INC. NA 82320DW

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization 20 GAUGE BUTTERFLY NEEDLE, MANUFACTURER UNK