BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRIOX SVO2/CCO PA 8F HEPARIN COATED CATHETER

    MDR report key: 6573598 · Received May 17, 2017

    Report

    Report Number
    2025816-2017-00116
    Event Type
    Malfunction
    Date Received
    May 17, 2017
    Date of Event
    March 31, 2017
    Report Date
    April 5, 2017
    Manufacturer
    ICU MEDICAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K821057
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: ONE USED 52510-14 TRIOX¿ SVO2/CCO CATHETER, UNKNOWN MFGERS. TOUCH CONTAMINATION SHEATH COVERED THE CATHETER FROM THE 70 TO 100 CM MARKS VISUAL INSPECTION AND ANALYSIS (PRE AND POST DECONTAMINATION) WAS PERFORMED. THE QE REPORT DOCUMENTS ONE OF THE 52510-14 FIBER OPTICS WAS OBSERVED TO BE MUCH LOWER IN LIGHT INTENSITY. THERE WERE NO OTHER VISUAL SURFACE/MATERIAL ANOMOLIES NOTED. QE TESTING AND ANALYSIS: THE CATHETER WAS CONNECTED TO A IN-HOUSE Q2 MONITOR AND CALIBRATION TESTED. THE RESULTS RECORDED THE CATHETER FAILED MULTIPLE ATTEMPTS TO CALIBRATE. THE CATHETER WAS THEN DISSECTED AND ANALYZED. THE QE ANALYSIS DOCUMENTS COMPONENT DAMAGES FOUND ON THE TIP OF THE CATHETER. THE ROOT CAUSE(S) OF THE DAMAGE TO THE FIBER OPTIC/CATHETER TIP COULD NOT BE DETERMINED. MFG. LOT BUILD REVIEW A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE REPORTED LOT# 3381532 (MFG. 01/2017) SHOWED 138 UNITS WERE MFG., 100% FUNCTIONALLY TESTED, 100% INSPECTED & RELEASED FINDINGS: TESTING AND ANALYSIS OF THE ONE RETURNED 52510-14 DEVICE CONFIRMED THE REPORTED CALIBRATION ISSUE. THE ROOT CAUSE OF THE CALIBRATION FAILURE WAS DUE TO COMPONENT DAMAGES. THERE WERE NO VISUAL SURFACE/MATERIAL ANOMOLIES NOTED THAT MAY HAVE CAUSED/CONTRIBUTED TO THE REPORTED INSERTION ISSUE. IT IS UNKNOWN IF THERE WERE ANY ANATOMICAL ANOMOLIES THAT MAY HAVE CONTRIBUTED TO THE REPORTED CATHETER INSERTION/PLACEMENT ISSUE.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING MULTIPLE ISSUES WITH USE OF 52510-14 TRIOX¿ SVO2/CCO PA 8F HEPARIN COATED CATHETERS. THE INITIAL INFORMATION RECEIVED REPORTS ".. CATHETERS FAILED TO CALIBRATE WITH TWO DIFFERENT OPTICAL MODULE CABLES .." AND "CLINICIANS WERE UNABLE TO FLOAT CATHETER .. (ATTEMPTED INSERTION) ...". THE DEVICES WERE REMOVED, REPLACED AND ALL BUT ONE (1) 52510-14 CATHETER WAS DISCARDED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES. ADDITIONAL INFORMATION ALTHOUGH REQUESTED BY THE MANUFACTURER WAS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354042 TRIOX SVO2/CCO PA 8F HEPARIN COATED CATHETER TRIOX¿ SVO2/CCO PA 8F HEPARIN COATED CATHETER DYG ICU MEDICAL INC. 52510-14 3381532

    Patients

    Seq Age Sex Outcome Treatment
    1