BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIMVENT MULTI-PORT, DSY, ENDO, REP CATH 16FR, ALT CODE 240165

    MDR report key: 6301818 · Received February 3, 2017

    Report

    Report Number
    8030647-2017-00022
    Event Type
    Injury
    Date Received
    February 3, 2017
    Date of Event
    January 26, 2017
    Report Date
    March 7, 2017
    Manufacturer
    HALYARD HEALTH
    Product Code
    BSY
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL EXAMINATION OF THE SAMPLE REVEALED THAT THE SAMPLE WAS RECEIVED WITH THE SEAL CASSETTE SECURELY ATTACHED TO THE ROTARY MANIFOLD. THE SEAL CASSETTE CAP WAS ATTACHED TO THE CASSETTE BODY. NO BREAKS, CRACKS, OR OTHER DAMAGED WAS OBSERVED. THE CAP WAS OPENED AND CLOSED MULTIPLE TIMES IN SUCCESSION. EACH TIME, A DISTINCT "CLICK" WAS HEARD AS THE CAP ENGAGED/SEATED INTO THE CLOSED POSITION AND WHEN THE CAP WAS OPENED. SECURE CLOSURE WAS OBSERVED. THE CAP SEATED FLUSH WITH THE TOP OF THE CASSETTE BODY WHEN IN THE CLOSED POSITION. THE CAP HAD TO BE PULLED OPEN. NO UNINTENDED OPENING OCCURRED. THE REPORTED EVENT COULD NOT BE CONFIRMED. NO ROOT CAUSE COULD BE IDENTIFIED, AS THE COMPLAINT COULD NOT BE CONFIRMED. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE HALYARD HEALTH COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT (B)(4).

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS REPORTED TO BE AVAILABLE, BUT HAS NOT YET BEEN RECEIVED BY THE MANUFACTURER. THE DEVICE HISTORY RECORD FOR M6152T803 WAS REVIEWED AND THE PRODUCT WAS PRODUCED ACCORDING TO PRODUCT SPECIFICATIONS. HALYARD HEALTH HAS NO INDEPENDENT KNOWLEDGE OF THE EVENT REPORTED BUT IS RELAYING THE INFORMATION THAT WAS PROVIDED BY THE USER FACILITY WHERE THE INCIDENT OCCURRED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CAP ON THE SEAL CASSETTE CAME OFF, RESULTING IN LOSS OF VENTILATION OF THE PATIENT. THE PATIENT DESATURATED (VALUE <50% OF SAO2) WITH A BRADYCARDIA AT 40 BEATS/MINUTE. THE PATIENT WAS IMMEDIATELY VENTILATED WITH A MASK AND THERE WERE NO SERIOUS CONSEQUENCES. NO FURTHER INFORMATION HAS BEEN REPORTED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84634 KIMVENT MULTI-PORT, DSY, ENDO, REP CATH 16FR, ALT CODE 240165 VAP CLOSED SUCTION CATHETERS & ACCESSORIES BSY HALYARD HEALTH 240165-5 M6152T803

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention