BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TEGO¿ CONNECTOR

    MDR report key: 21411701 · Received February 19, 2025

    Report

    Report Number
    9617594-2025-00315
    Event Type
    Injury
    Date Received
    February 19, 2025
    Date of Event
    December 27, 2024
    Report Date
    April 22, 2025
    Manufacturer
    ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
    Product Code
    FPA
    UDI-DI
    00840619026059
    PMA / PMN Number
    K053106
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN B2.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION CAN BE FOUND IN B1, B2 AND H1.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR EVALUATION- IT HAS NOT BEEN RECEIVED. THE INVESTIGATION IS PENDING.

    Additional Manufacturer Narrative · 0

    RECEIVED FIVE NEW D1000 TEGO CONNECTORS FOR INSPECTION. NO DEFECTS OR ANOMALIES NOTED. THE TEGO WAS ACCESSED WITH A LUER LOCK SYRINGE TO ACTIVATE THE DEVICES. THERE WERE NO ISSUES CONNECTING OR A PROPENSITY TO DISCONNECT. THE MALE LUER OF EACH TEGO WAS MEASURED AND FOUND TO MEET ISO STANDARDS. THE REPORTED COMPLAINT WAS UNABLE TO BE REPLICATED OR CONFIRMED. D9 - DATE RETURNED TO MFG: 26FEB2025. ADDITIONAL INFORMATION CAN BE FOUND IN B5, B6, D10 H6 HEALTH EFFECT - IMPACT CODE AND H6 MEDICAL DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE INVOLVING A TEGO¿ CONNECTOR WHERE THE CUSTOMER REPORTED THAT A PATIENT UNDERGOING HOME DIALYSIS (HEMODIALYSIS) EXPERIENCED A DISCONNECTION OF THE TEGO VALVE AT THE END OF THE DIALYSIS SESSION. THIS RESULTED IN A HEMORRHAGE REQUIRING HOSPITALIZATION. THERE WAS PATIENT INVOLVEMENT AND ADVERSE EVENT/HUMAN HARM.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 31JAN2025 AS FOLLOWS: THE REPORTER STATED THAT HERE WAS CLINICALLY SIGNIFICANT BLOOD LOSS, ESTIMATED TO BE BETWEEN 51ML AND 100ML, WITH AN APPROXIMATE 1-POINT DROP IN HEMOGLOBIN. THE PATIENT WAS REPORTEDLY ANXIOUS DURING THE EVENT. AFTER THE INCIDENT, THE PATIENT REQUIRED 2 RBC UNITS TO BE TRANSFUSED ON (B)(6) 2024 AND REQUIRED FURTHER MONITORING DURING THEIR HOSPITALIZATION. THE HEMODIALYSIS SYSTEM THAT WAS IN USE AT THE TIME WAS HDQ CYCLEUR NXSTAGE. FEINJECT, ARANESP, CITRAFLOW WERE USED WITH THE CIRCUIT AT THE TIME. THE DIALYSES LINE WAS A CASSETTE AVEC PURÉMA 1.6 M² HF NXSTAGE, REFERENCE #: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2669274 TEGO¿ CONNECTOR SET, ADMINISTRATION, INTRAVASCULAR FPA ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN 00840619026059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H ARANESP, MFR UNK.| CASSETAVECPURÉMA1.6M²HFNXSTAGERF#CAR172C, MFR UNK.| FEINJECT, MFR UNK.| HDQ CYCLEUR NXSTAGE. HD SYSTEM, MFR FRESINEUS.