BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO¿ CONNECTOR

    MDR report key: 16238568 · Received January 25, 2023

    Report

    Report Number
    9617594-2023-00036
    Event Type
    Malfunction
    Date Received
    January 25, 2023
    Date of Event
    November 7, 2022
    Report Date
    January 12, 2023
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE TO BE RETURNED FOR EVALUATION; HOWEVER, IT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION: LOT NUMBER 5916730: MFR DATE: 4/2022, EXPIRY DATE: 4/2027. 5891775: MFR DATE: 4/2022, EXPIRY DATE: 3/2027. 5891769: MFR DATE: 4/2022, EXPIRY DATE: 3/2027.

    Additional Manufacturer Narrative · 0

    THE RECEIVED NEW D1000 TEGO CONNECTORS WERE MEASURED AND FUNCTIONALLY TESTED FOR LEAKAGE. BOTH ASSEMBLIES MET DESIGN AND PERFORMANCE EXPECTATIONS. THE COMPLAINT OF LEAKAGE RESULTING FROM CONNECTION TO THE D1000 TEGO ASSEMBLIES WAS UNABLE TO BE REPLICATED OR CONFIRMED. LOT HISTORY RECORDS FOR THE POSSIBLE LOT NUMBERS WERE REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT. ADDITIONAL INFORMATION: PRODUCT RECEIVE DATE: 3/6/2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TEGO CONNECTOR WAS NOT ATTACHING TO THE LINE PROPERLY. THE EXAMINATION, RESULTS, AND COMMENTS STATED: EXAMINATION IN THE LABORATORY IDENTIFIED A POSSIBLE COMPATIBILITY ISSUE BETWEEN THE TEGO HEMODIALYSIS CONNECTOR AND NOVALINE HAEMODIALYSIS TUBING SETS WHICH MAY HAVE CONTRIBUTED TO THE CLINICAL INCIDENT. TWO AND A HALF HOURS INTO A 4-HOUR HEMODIALYSIS SESSION, THE ARTERIAL LINE HAD DISCONNECTED FROM THE PATIENT'S PERMCATH RESULTING IN AIR BEING PULLED THROUGH THE MACHINE, HOWEVER, NO AIR REACHED THE PATIENT AND THE PATIENT WAS NOT AT RISK. IT WAS LATER DISCOVERED THAT THE TEGO WAS NOT ATTACHING TO LINES PROPERLY. THE LOCATION OF THE FAULTY LOCK WAS THE SILICONE-SHEATHED LUER CONNECTION BETWEEN THE TEGO AND THE TUBING SET. THERE WAS NO HARM TO THE PATIENT REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PATIENT LOST PART OF THEIR HEMODIALYSIS (HD) CIRCUIT. THIS MEANS A SMALL AMOUNT OF BLOOD WAS LOST IN THE HD CIRCUIT (<15MLS)." THE CUSTOMER STATED THAT THE "PATIENT'S HEMODIALYSIS MACHINE WAS MADE UP AGAIN AND DIALYSIS RESTARTED". THERE WAS NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    785883 TEGO¿ CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. D1000 PLOTS

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOVALINE HAEMODIALYSIS TUBING SET| PERMACATH, UNK MFR