BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TRIOX SVO2/CCO PA CATHETERS

    MDR report key: 5591399 · Received April 20, 2016

    Report

    Report Number
    2025816-2016-00028
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Report Date
    February 24, 2016
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DQE
    PMA / PMN Number
    K06299
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL MFG. LOT BUILD REVIEWS: A REVIEW OF THE MFG. LOT BUILD DATABASE FOR THE TWO REPORTED LOT# RECORDED LOT# 3139123 (MFG.11/2015) SHOWED (B)(4) UNITS AND LOT# 3077504 (MFG. 07/2015) SHOWED (B)(4) UNITS WERE ALL MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILDS. QE INVESTIGATION IS IN PROGRESS.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING INTERMITTENT SVO2 READING ISSUES WITH USE OF 52511-14 8F TRIOX SVO2/CCO PA CATHETERS. INFORMATION RECEIVED REPORTS THERE WERE FOUR EVENTS (POST OP) WHERE SVO2 READING FAILURES OCCURRED AND WERE DESCRIBED AS FOLLOWS ".. PRE-INSERTION CALIBRATION WOULD NOT COMPLETE EVEN WITH MULTIPLE OP MODS. ONCE FLOATED, CATHETER WOULD NOT READ SV02. UNABLE TO SEE LIGHT ON Q2+. OP MOD HAD LIGHT COMING FROM TIP.". ATTENDING MEDICAL STAFF/CLINICIANS ARE HAVING TO DRAW MANUAL GASSES EVERY FOUR HOURS FOR UP TO 2 DAYS ...(AFFECTING) . TIMELY ADMINISTRATION OF MEDICAL TREATMENTS. THERE WERE NO REPORTED PATIENT INJURIES AND OR ADVERSE PATIENT OUTCOMES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244069 8F TRIOX SVO2/CCO PA CATHETERS 8F TRIOX¿ SVO2/CCO PA CATHETERS DQE ICU MEDICAL, INC. 52511-14 3139123; 3077504

    Patients

    Seq Age Sex Outcome Treatment
    1