BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 9861179 · Received March 20, 2020

    Report

    Report Number
    9617594-2020-00080
    Event Type
    Malfunction
    Date Received
    March 20, 2020
    Date of Event
    March 5, 2020
    Report Date
    March 10, 2020
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026059
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 0

    H10 - NO PRODUCT SAMPLES WERE RETURNED FOR INVESTIGATION; HOWEVER, A SERIES OF PHOTOGRAPHS WERE RETURNED SHOWING USED D1000 TEGO ASSEMBLIES WITH VISUAL EVIDENCE OF BLOOD RESIDUALS SUGGESTING THAT THE PRODUCTS HAD BEEN IN USE. THE YELLOW BODIES APPEARED TO HAVE BEEN CRUSHED/CRACKED AT THE FEMALE LUER END OF THE USED D1000 TEGO ASSEMBLIES. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE USED D1000 TEGO ASSEMBLIES. SINCE THESE SAMPLES HAD BEEN USED IT IS NOT KNOWN WHEN, WHERE, OR WHY THE CRACKING OCCURRED BUT IT DOES NOT APPEAR TO HAVE BEEN WHILE IN THE CONTROL OF ICU MEDICAL. THE PROBABLE CAUSE OF THE CRUSHED/CRACKED D1000 TEGO ASSEMBLIES CANNOT BE DETERMINED. THE DEVICE HISTORY REVIEW (DHR) FOR LOT 4150902 WAS REVIEWED AND THERE WERE NO RELEVANT NON-CONFORMANCES FOUND THAT WOULD HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

    Additional Manufacturer Narrative · 0

    D10 - DATE RETURNED TO MFG - MAY 8, 2020. H10 - ONE USED LIST # D1000, TEGO¿ CONNECTOR; LOT # 4150902 WAS RETURNED FOR EVALUATION. NO MATING DEVICES WERE RETURNED TO EVALUATE WITH THE TEGO ASSEMBLY. THE D1000 TEGO ASSEMBLY HAD VISIBLE EVIDENCE OF CRACKING AT THE FEMALE END OF THE ASSEMBLY. THE CRACKING AT THE FEMALE END OF THE D1000 TEGO ASSEMBLY WAS TYPICAL OF BEING CRUSHED. SINCE THE SAMPLE HAD BEEN USED IT IS NOT KNOWN WHEN, WHERE, OR WHY THE CRUSHED/CRACKING OCCURRED. THE PROBABLE CAUSE OF THE CRUSHED/CRACKED D1000 TEGO ASSEMBLY THAT LEAD TO LEAKAGE CANNOT BE DETERMINED. ADDITIONAL INFORMATION CAN BE FOUND IN SECTION D10.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT EXPECTED TO RETURN FOR EVALUATION. THE CUSTOMER HAS PROVIDED PHOTOGRAPHS FOR EVALUATION. TESTING IS NOT COMPLETE.

    Description of Event or Problem · 1

    THE EVENT INVOLVED A TEGO CONNECTOR THAT WAS FOUND TO BE CRACKED AT THE START OF DIALYSIS AND ASPIRATION OF AIR INTO THE ARTERIAL LINE OF THE DIALYSIS GENERATOR WAS NOTED, REQUIRING ADJUSTMENT OF THE LEVELS OF THE ARTERIAL AND VENOUS TRAPS OF THE EXTRA CORPOREAL CIRCUIT AND THE EVACUATION OF AIR PRESENT IN THE CIRCUIT. THE VALVE WAS IMMEDIATELY REMOVED. THE TEGO CONNECTOR ALSO SHOWED A PRESENCE OF BLOOD BETWEEN THE VALVE (YELLOW PART) AND THE TRANSPARENT PLASTIC THAT ENVELOPS THE VALVE, WHICH WAS LIKELY DUE TO THE CRACKED VALVE. THE DEVICE HAD BEEN INSTALLED ON (B)(6) 2020. THE PATIENT WAS CONNECTED WHEN THE EVENT OCCURRED, BUT THERE WAS NO BLOOD LOSS, NO CLINICAL CONSEQUENCES NOTED. THE STATUS OF THE PATIENT AFTER THE EVENT REMAINED UNCHANGED. THERE WAS NO DELAY IN THERAPY, NO MEDICAL OR SURGICAL INTERVENTION REQUIRED. THIS REPORT REFLECTS 2 OF 2 INCIDENTS FOR THE FIRST PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    322411 TEGO CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4150902 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1