BEUDAMED
    FDA Adverse Event Death Summary report: N

    60" EXT. SET

    MDR report key: 5647109 · Received May 11, 2016

    Report

    Report Number
    2025816-2016-00034
    Event Type
    Death
    Date Received
    May 11, 2016
    Date of Event
    April 12, 2016
    Report Date
    May 11, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K941190
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL RECEIVING INSPECTION: 04/27/2016 - RECEIVED THE FOLLOWING DEVICES: ONE (1) USED ICU MEDICAL LIST# B2032, 60" EXT SET LOT# UNKNOWN, ONE (1) USED 4-WAY STOPCOCK MANUFACTURER UNKNOWN, TWO (2) USED ICU MEDICAL CLAVES, LOT# UNKNOWN, ONE (1) USED TUBING EXTENSION 7 INCH, MANUFACTURER UNKNOWN AND ONE (1) USED BD 60ML SYRINGE. A USED B2032 SET WAS RETURNED FOR INVESTIGATION. A 50ML LUER LOCK SYRINGE WAS CONNECTED AT THE DISTAL END TO THE FEMALE LUER OF THE B2032 SET. A CLAVE WAS CONNECTED TO THE MALE LUER OF THE B2032 SET WHICH WAS CONNECTED TO THE FEMALE LUER THROUGH PORT OF A FOUR WAY STOPCOCK. A CLAVE WAS CONNECTED TO THE FEMALE LUER OF THE STOPCOCK SIDE PORT. AN UNKNOWN EXTENSION SET WAS CONNECTED TO THE MALE LUER OF THE STOPCOCK THROUGH PORT AND THE UNKNOWN EXTENSION SET WAS CONNECTED AT THE MALE LUER END TO A YELLOW DEAD-END CAP. THE STOPCOCK HANDLE WAS TURNED TO SO THAT THE SIDE PORT WAS IN THE OFF POSITION AND THE THROUGH PORTS WERE OPEN. THERE WAS BLOOD VISIBLE IN THE STOPCOCK SIDE PORT. INVESTIGATION: THE RETURNED SET WAS FLOW TESTED AT 25PSI. A STEADY STREAM OF WATER FLOWED FROM THE TUBING NEAR THE CENTER OF THE B2032 SET ASSEMBLY. MICROSCOPIC EXAMINATION REVEALED THAT THERE WAS A CUT IN THE TUBING THAT RESULTED IN LEAKAGE. THERE WAS ALSO ADHESIVE ON EITHER SIDE OF THE CUT, BUT NOT IN THE CUT ITSELF. THIS SUGGESTS THAT THE CUT OCCURRED DURING USE. THE SET WAS CLAMPED IN SEVERAL AREAS OTHER THAN THE LOCATION OF THE CUT. THERE WAS NO LEAKAGE OBSERVED EXCEPT AT THE SITE OF THE CUT. ANALYSIS SUMMARY: THE COMPLAINT OF LOSS OF TUBING INTEGRITY FROM THE B2032 SET WAS VERIFIED. THE LOSS OF TUBING INTEGRITY WAS DUE TO A PHYSICAL CUT PRESENT ON THE TUBING THAT MOST LIKELY OCCURRED DURING USE. IF THE CUT WERE TO BE PRESENT PRIOR TO USE, IT WOULD HAVE BEEN DETECTED IMMEDIATELY DURING PRIMING OR WOULD HAVE BEEN VISUALLY OBSERVED DUE TO ITS SIZE AS A TAPE WAS PLACED ON THAT LOCATION AS EVIDENCED BY PRESENCE OF ADHESIVE FIBERS AT THAT LOCATION. ALL OTHER COMPONENTS AND CONNECTIONS IN THE FLUID CIRCUIT WERE PRESSURE TESTED WITHOUT LEAKAGE. BASED ON THE EXAMINATION AND RESULTS DESCRIBED ABOVE, WHILE THE EXACT ROOT CAUSE FOR THE CUT CANNOT BE DETERMINED, THE MOST LIKELY CAUSE COULD BE RELATED TO SOME TYPE OF A SHARP INSTRUMENT COMING IN CONTACT WITH THE TUBING DURING USE POSSIBLY WHILE REMOVING THE MEDICAL TAPE USED TO AFFIX THE TUBING TO THE PATIENT OR A SOLID SURFACE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REGARDING ONE B2032, 60" EXT SET, LOT# UNKNOWN. REPORT STATES, PATIENT TO OPERATING ROOM IN PLANS OF CONVERSION OF ECMO TO A LVAD. PERFUSION NOTED DRAMATIC CHANGES IN ECMO FLOWS. LARGE AMOUNT OF AIR NOTED IN BOTH ARTERIAL AND VENOUS LIMBS OF ECMO CIRCUIT WITH NO PERFUSION. CPR INITIATED, ECMO CANNULAE ATTEMPTED TO BE PURGED OF AIR BY PERFUSION STAFF. HOWEVER, DUE TO MASSIVE AIR EMBOLUS RESUSCITATION UNSUCCESSFUL. AFTER DISCUSSION WITH CICU, TRANSPLANTATION SERVICE, ANESTHESIA, A DECISION WAS MADE NOT TO PROCEED WITH ANY ADDITIONAL MEASURES. PATIENT PRONOUNCED AND FAMILY CARE CONFERENCE WAS HELD WITH PATIENT'S MOTHER. THE IV TUBING LINE ATTACHED TO THE VENOUS LUER PORT, SUFFERED A LOSS IN TUBING INTEGRITY THAT OFFERED AN OPPORTUNITY TO ENTRAIN AIR INTO THE ECMO CIRCUIT. AIR DISPLACED BLOOD IN THE CIRCUIT TRAVELING TO THE CANNULATION SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301543 60" EXT. SET EXT. SET FPA ICU MEDICAL, INC. B2032 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Death