BEUDAMED
    FDA Adverse Event Death Summary report: N

    HUDSON RESERVOIR, CONCHA MINI 760 ML

    MDR report key: 3795701 · Received April 24, 2014

    Report

    Report Number
    1417411-2014-00020
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 24, 2014
    Manufacturer
    TELEFELX MEDICAL
    Product Code
    BTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SEVERAL ATTEMPTS MADE, VIA PHONE, BY (B)(4) (TELEFLEX REGULATORY AFFAIRS) TO OBTAIN ADDITIONAL INFO RELATED TO THIS EVENT. (B)(4) (TELEFLEX) SPOKE WITH RESPIRATORY STAFF MEMBER WHO COULD NOT PROVIDE ANY ADDITIONAL INFO. ALSO, (B)(4) (TELEFLEX) SPOKE WITH THE RISK MANAGER WHO COULD NOT PROVIDE ANY ADDITIONAL INFO RELATED TO THE EVENT. THE RISK MANAGER STATED THAT SHE WOULD PROVIDE ANY ADDITIONAL INFO IF AVAILABLE, BUT TO DATE NO ADDITIONAL INFO HAS BEEN RECEIVED. A VISUAL, FUNCTIONAL AND DIMENSIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. NO DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED SINCE CUSTOMER DID NOT PROVIDED LOT NUMBER. THE COMPLAINT INVESTIGATOR REQUESTED ADDITIONAL CLARIFICATION REGARDING THE THERAPY PERFORMED AND LOT NUMBER OF THE WATER BOTTLE. THE COMPANY IS INVESTIGATING THE OCCURRENCE RATE FOR THIS ISSUE. THE WATER BOTTLE SAMPLE, TUBING THAT DISCONNECTED SAMPLE ALONG WITH OTHER ANCILLARY PART SAMPLES USED IN THIS PROCEDURE ARE NEEDED TO DETERMINE ROOT CAUSE. TELEFLEX WILL CONTINUE TO MONITOR FEEDBACK FROM CUSTOMERS ON ISSUES RELATED TO TUBE DISCONNECTING FROM THE WATER BOTTLE CONTAINER AT SETUP OR DURING USE IN THERAPY.

    Description of Event or Problem · 1

    THE EVENT IS REPORTED AS: THE CUSTOMER ALLEGES THAT THE TUBING (BOTTOM CONNECTION) THAT WAS CONNECTED TO THE 760 ML WATER BOTTLE DISCONNECTED FROM THE WATER RESULTING IN THE PT NOT RECEIVING OXYGEN. THE PT'S OXYGEN SATURATION LEVEL DE-SATURATED INTO THE 70'S. THE SATURATION LEVEL RECOVERED. A PT DEATH OCCURRED THREE HOURS POST INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248422 HUDSON RESERVOIR, CONCHA MINI 760 ML RESERVOIR (STERILE WATER BOTTLE) BTT TELEFELX MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HI FLOW NASAL CANNULA| CONCHA NEPTUNE