BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TRIOX SVO2/CCO PA CATHETERS

    MDR report key: 5591055 · Received April 20, 2016

    Report

    Report Number
    2025816-2016-00024
    Event Type
    Malfunction
    Date Received
    April 20, 2016
    Report Date
    February 17, 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 THREE REPORTED LOT# RECORDED LOT# 3124651 (MFG.10/2015) SHOWED (B)(4) UNITS; LOT# 3086248 (MFG.07/2015) ALSO SHOWED (B)(4) UNITS AND LOT# 3129155 (MFG. 10/2015) 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, MULTIPLE LOT# . THE INITIAL INFORMATION RECEIVED REPORTS OVER THE PAST TWO WEEKS UNSPECIFIED NUMBER OF OCCURRENCES (PRE AND POST OP) WHERE SVO2 READING FAILURES OCCURRED. THE INITIAL INFORMATION RECEIVED REPORTS ".. 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.". ONE EVENT WAS DESCRIBED AS FOLLOWS " ..AFTER PLACEMENT OF CATHETER ATTEMPTS TO OBTAIN SV02 READINGS WERE UNSUCCESSFUL, THE CATHETER WAS REMOVED AND REPLACED WITH A SECOND CATHETER WHICH ALSO FAILED TO PROVIDE SVO2 READINGS. ATTENDING MEDICAL STAFF/CLINICIANS ARE HAVING TO DRAW MANUAL GASSES EVERY FOUR HOURS FOR UP TO 2 DAYS WHICH IS CAUSING "CRITICAL DELAYS IN ASSESSMENTS ... TIMELY ADMINISTRATION OF MEDICAL TREATMENTS." THERE WERE NO REPORTED PATIENT INJURIES AND OR ADVERSE PATIENT OUTCOMES. REPORTED LOT# 3124651 (MFG.10/2015) (B)(4) UNITS; 3086248 (MFG.07/2015) (B)(4) UNITS; 3129155 (MFG. 10/2015) (B)(4) UNITS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244154 8F TRIOX SVO2/CCO PA CATHETERS 8F TRIOX¿ SVO2/CCO PA CATHETERS DQE ICU MEDICAL, INC. 52511-14 3124651;3086248;3129155

    Patients

    Seq Age Sex Outcome Treatment
    1