BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGO CONNECTOR

    MDR report key: 8902778 · Received August 16, 2019

    Report

    Report Number
    9617594-2019-00278
    Event Type
    Injury
    Date Received
    August 16, 2019
    Date of Event
    July 24, 2019
    Report Date
    July 24, 2019
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    H10: NO D1005 PRODUCT SAMPLES, VIDEOS, OR PHOTOGRAPHS WERE RETURNED FOR INVESTIGATION. NO DHR LOT REVIEW WAS CONDUCTED BECAUSE NO LOT NUMBER(S) WAS/WERE IDENTIFIED. A PROBABLE CAUSE CANNOT BE IDENTIFIED BASED ON THE INFORMATION THAT HAS BEEN PROVIDED. ADDITIONAL INFORMATION IN D10 AND G1.

    Additional Manufacturer Narrative · 0

    CONCOMITANT PRODUCTS: COMMON DEVICE NAME: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM. MFR: NXSTAGE MEDICAL, INC., 350 MERRIMACK ST., LAWRENCE, MA, 01843, MODEL NUMBER: NX-1000-5-A, SERIAL NUMBER: (B)(6), BRAND NAME: NXSTAGE SYSTEM ONE, AGE OF DEVICE: 2 YEARS. COMMON DEVICE NAME: STOPCOCK, I.V. SET, BRAND NAME: BD CONNECTA PLUS STOPCOCK, MFR: BD, SAN ANTONION, TX, MODEL NUMBER: 394910, CATALOG NUMBER: 394910.

    Description of Event or Problem · 0

    UFMW RECEIVED ON OCTOBER 2, 2019. ¿STAFF DESCRIPTION: PT BECAME DISCONNECTED FROM RETURN PORT OF CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) AND WAS PUMPING BLOOD INTO THE BED. NO ALARMS WENT OFF ON CIRCUIT. DISCONNECTION WAS NOTED WHEN BLOOD PRESSURE DROPPED. CRRT WAS STOPPED AND LINES WERE CLAMPED. THERE APPEARED TO BE SEVERAL HUNDRED ML OF BLOOD IN THE BED. BLOOD PRESSURE STABILIZED WITH INCREASED PRESSORS AND STOPPING OF CRRT. MACHINE BROUGHT TO CLINICAL TECHNOLOGY FOR EVALUATION. SENT LOG FILE TO MANUFACTURER FOR REVIEW. VERIFIED PARAMETERS. PRIME AND ALARMS TESTS-PASSES. MOCK TREATMENT. TRIGGERED VENOUS HIGH PRESSURE TO TEST AUDIBLE ALARM-AUDIBLE ALARM OCCURRED. MACHINE APPEARS TO BE WORKING PER SPECIFICATIONS. ACCORDING TO THE MACHINE LOG, THE VENOUS RETURN PRESSURE WAS AROUND 90MMHG JUST PRIOR TO DISCONNECT. PRESSURE THEN DROPPED TO AROUND 36MMHG. ALARM LIMIT WAS SET AT 20MMHG. BLOOD FLOW RATE WAS 200ML/MIN. BLOOD LOSS ESTIMATE WAS AROUND 1000ML. A KEY FACTOR APPEARS TO BE THE USE OF THE TEGO PORT AND THE 3-WAY STOPCOCK ON THE VENOUS RETURN LINE. THE STOPCOCK WAS A NEWLY INTRODUCED MODEL AND MAY BE MORE PRONE TO NOT LOCKING PROPERLY ON THE THREADS. THE LINE DISCONNECTED WHERE THE STOPCOCK WAS ATTACHED TO THE TEGO PORT. ANOTHER FACTOR IS THE SMALL BORE OF THE STOPCOCK AND TEGO CONNECTOR PROVIDED ENOUGH BACK PRESSURE TO PREVENT THE LOW PRESSURE ALARM FROM TRIGGERING.¿

    Additional Manufacturer Narrative · 1

    SAMPLES ARE AVAILABLE FOR EVALUATION. THEY ARE YET TO BE RECEIVED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A TEGO CONNECTOR BECAME DISCONNECTED DURING CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) RESULTING IN A BLOOD LOSS OF 1400MLS. THE PATIENT REQUIRED EMERGENCY BLOOD TRANSFUSION WITH 2 UNITS OF PACKED RED BLOOD CELLS (PRBC) AND INCREASED VASOPRESSOR DOSE. PER THE VASCULAR SALES SPECIALIST, EVENT WAS NOT DUE TO A QUALITY ISSUE WITH THE TEGO BUT RATHER THE ADDITION OF A BD STOPCOCK THAT WAS NOT COMPATIBLE WITH THE TEGO THUS RESULTING IN HIGH PRESSURES DURING CRRT. THE STOPCOCK WAS VERY BASIC AND A SPIN MALE LUER THAT DIDN¿T FULLY SECURE TO THE TEGO. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    695613 TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Required Intervention BD STOPCOCK.