BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUE

    MDR report key: 9371718 · Received November 25, 2019

    Report

    Report Number
    9617594-2019-00406
    Event Type
    Malfunction
    Date Received
    November 25, 2019
    Date of Event
    November 6, 2019
    Report Date
    November 12, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FMG
    UDI-DI
    00840619059699
    PMA / PMN Number
    K964435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 - DATE RETURNED TO MFG: 1/6/2020 H10 - ONE USED 011-H3424, 12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUER (LOT# 4060290) WAS RECEIVED AND VISUALLY INSPECTED. AS RECEIVED, NO DAMAGE OR ANOMALIES WERE IDENTIFIED ON THE SET. THE USED 011-H3424 SET WAS PRIMED AND HYDROSTATIC PRESSURE LEAK TESTED ACCORDING TO PRODUCT PERFORMANCE SPECIFICATIONS. EACH OF THE CHECK VALVES PRIMED WITHOUT DIFFICULTY. THE CHECK VALVES WERE TESTED FOR BACK PRESSURE CAPABILITY. EACH MET PRODUCT PERFORMANCE SPECIFICATIONS WITHOUT BACK FLOW. NO LEAKAGE WAS OBSERVED AT ANY LOCATION ALONG THE FLUID PATH. NO MATING DEVICES WERE RETURNED. THE REPORTED COMPLAINT COULD NOT BE CONFIRMED OR REPLICATED. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION D10.

    Additional Manufacturer Narrative · 0

    NO PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 4060290 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. THE COMPLAINT CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. IF PRODUCT IS RETURNED IN THE FUTURE, THE COMPLAINT WILL BE RE-OPENED AND THE SAMPLE WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO RETURN FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A 12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUER, AT THE SURGERY INTENSIVE CARE UNIT, WHERE THERE WAS A LEAKAGE OF THE DEVICE WHEN INFUSING NORADRENALINE. THE PATIENT¿S UNSPECIFIED CENTRAL VENOUS LINE WAS CONNECTED TO A BD CONNECTA - 3 CHANNEL CONNECTOR, WHICH WAS CONNECTED TO THE TRIFUSE EXTENSION SET, THEN AN EXTENSION SET OF A SYRINGE PUMP. IT WAS REPORTED THAT THE PATIENT ARRIVED AT THE SURGERY INTENSIVE CARE UNIT IN SHOCK WITH A VERY LOW BLOOD PRESSURE. THE NURSE INTERVENED WITH EQUIPMENT AND CATECHOLAMINES TO STABILIZE THE BLOOD PRESSURE. AFTER SEVERAL MINUTES, WHEN THE BLOOD PRESSURE WAS STILL LOW, THE NURSE CHECKED THE CONNECTIONS OF THE CENTRAL VENOUS LINE, NOTING A LEAK AT THE EXIT OF THE 3 CHANNELS OF THE EXTENSION SET. THE DEVICE WAS DISCONNECTED AND THE NORADRENALINE WAS CONNECTED DIRECTLY TO THE PATIENT¿S LINE AND THE PATIENT¿S BLOOD PRESSURE STABILIZED. THERE WAS A REPORT OF A DELAY IN THERAPY FOR 30 MINUTES DURING THE LOSS OF CATECHOLAMINES. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1164790 12 CM (5") PUR SMALLBORE TRIFUSE EXT SET, 3 CHECK VALVES, 3 CLAMPS, ROTATING LUE STOPCOCK, I.V. SET FMG ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4060290 00840619059699

    Patients

    Seq Age Sex Outcome Treatment
    1 BD CONNECTA, REF (B)(4).| EXT SET, REF PA-200-6, MFR CAREFUSION| NORADRENALINE, MFR UNK| UNSP CENTRAL VENOUS CATHETER, UNK MFR| UNSP SYRINGE PUMP