BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEGO CONNECTOR

    MDR report key: 5915583 · Received August 30, 2016

    Report

    Report Number
    2025816-2016-00117
    Event Type
    Malfunction
    Date Received
    August 30, 2016
    Report Date
    July 14, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    PMA / PMN Number
    K053106
    Removal / Correction Number
    2025816-09/01/2016-005-R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    MFG. LOT BUILD REVIEW - A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE THREE "POTENTIAL" LOT# WAS PERFORMED. THE RESULTS RECORDED LOT# 3254636 (MFG. 05/2016) SHOWED (B)(4) UNITS; LOT# 3265974 (MFG.05/2016) ALSO SHOWED (B)(4) UNITS WERE ALL MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED. DEVICE RETURN: ONE USED D100 TEGO CONNECTOR; THIRTY-EIGHT (38) PACKAGED D1000 TEGO CONNECTORS LOT# 325974; SEVEN (7) PACKAGED D1000 TEGO CONNECTORS LOT# 3176487; FIVE (5) PKGD. D1000 TEGO CONNECTORS LOT#3200037; TWO (2) PACKAGED D1000 TEGO CONNECTORS LOT# 3239846; ONE HUNDRED FIFTY-TWO (152) PKGD. D1000 TEGO CONNECTORS LOT# 3254636 ENGINEERING TESTING AND ANALYSIS OF THE ONE RETURNED USED AND (B)(4) PACKAGED TEGO SAMPLES WAS PERFORMED. THE RESULTS RECORDED MIXED FINDINGS. FINDINGS: TESTING AND ANALYSIS RECORDED LEAKAGE/FAILURES WITH TWENTY-TWO (22) OF THE (B)(4) TEGO CONNECTORS THAT WERE RETURNED. ADDITIONAL ENGINEERING EFFORTS DID IDENTIFY COMPONENT/MOLDING ANOMALY THAT MAY HAVE CAUSED OR CONTRIBUTED TO A SEAL MISALIGNMENT . THIS CONDITION COULD RESULT IN INTERNAL LEAKAGE. ICU MEDICAL INC. HAS IDENTIFIED THE POTENTIAL RISK OF LEAKING WITH CERTAIN TEGO® CONNECTOR DEVICES. THE POTENTIAL FOR LEAKAGE COULD EXIST WHEN THE TEGO IS CONNECTED TO THE DIALYSIS TUBING DURING THE HEMODIALYSIS TREATMENT, AND MAY LEAD TO BLOOD LOSS. ICU MEDICAL HAS RECEIVED REPORTS ASSOCIATED WITH THIS ISSUE. ICU MEDICAL IS RECALLING LOTS THAT COULD POTENTIALLY CONTAIN THIS CONDITION. THERE HAVE BEEN NO REPORTS OF ADVERSE PATIENT CONSEQUENCES AS A RESULT OF THIS ISSUE. CORRECTIVE AND PREVENTATIVE ACTIONS: A DETAILED ANALYSIS OF THE TEGO DESIGN, MATERIALS, MANUFACTURING AND INSPECTION PROCESSES AND EQUIPMENT WAS PERFORMED. THE DATA AND ENGINEERING EFFORTS IDENTIFIED THE SEAL COMPONENT ANOMALY WAS ATTRIBUTABLE TO THE MANUFACTURING /MOLDING OPERATION DUE TO A CAVITY CORE PIN (EDGE). CORRECTIVE ACTIONS HAVE BEEN IDENTIFIED, QUALIFIED AND IMPLEMENTED.

    Additional Manufacturer Narrative · 1

    MFG. LOT BUILD REVIEW - A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE THREE "POTENTIAL" LOT# WAS PERFORMED. THE RESULTS RECORDED LOT# 3254636 (MFG. 05/2016) SHOWED 28000 UNITS; LOT# 3265974 (MFG.05/2016) ALSO SHOWED 28000 UNITS WERE ALL MFG. TESTED INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED. DEVICE RETURN: ONE USED D100 TEGO CONNECTOR; THIRTY-EIGHT (38) PACKAGED D1000 TEGO CONNECTORS LOT# 326974; SEVEN (7) PACKAGED D1000 TEGO CONNECTORS LOT# 3176487; FIVE (5) PKGD. D1000 TEGO CONNECTORS LOT#3200037; TWO (2) PACKAGED D1000 TEGO CONNECTORS LOT# 3239846; ONE HUNDRED FIFTY-TWO (152) PKGD. D1000 TEGO CONNECTORS LOT# 3254636. QE ANALYSIS AND INVESTIGATION IN PROGRESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING LEAKAGE ISSUE WITH USE OF UNSPECIFIED DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS WERE IN USE. INITIAL INFORMATION REPORTS THERE HAVE BEEN FOUR INCIDENTS WHERE CLINICIANS FOUND "..TEGO CAPS LEAKING ON THE SIDE DURING HEMODIALYSIS. TREATMENT. STAFF HAS TO INTERRUPT TREATMENT TO CHANGE AFFECTED PRODUCT FOR PATIENT SAFETY." THERE WERE NO REPORTED PATIENT INJURIES AND OR ADVERSE CONSEQUENCES. THE TEGO CONNECTORS WERE REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING LEAKAGE ISSUES WITH USE OF UNSPECIFIED DIALYSIS SET-UPS WHERE D1000 TEGO CONNECTORS WERE IN USE. LIMITED EVENT/USAGE INFORMATION RECEIVED. INITIAL INFORMATION REPORTS THERE HAVE BEEN FOUR INCIDENTS WHERE CLINICIANS FOUND "..BLOOD LEAKING OUT BETWEEN HOUSING AND SILICONE. .. ONE INCIDENT WHERE THERE WAS APPROX. AN INCH OF AIR NOTED IN THE ARTERIAL BLOOD TUBING RIGHT ABOVE THE CONNECTION SITE....." . THE TEGO CONNECTORS WERE REMOVED AND REPLACED WITH NO FURTHER ISSUES ENCOUNTERED. FACILITY REPORTS THEY HAVE HAD NO FURTHER ISSUES WITH THE TEGO SINCE (B)(6) 2016. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    566705 TEGO CONNECTOR TEGO CONNECTOR FPA ICU MEDICAL, INC. D1000 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1