BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HUDSON ADULT HEATED WIRE CIRCUIT DUAL LIMB

    MDR report key: 3123704 · Received May 14, 2013

    Report

    Report Number
    3004365956-2013-00132
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 23, 2013
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    CAI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL, DIMENSIONAL AND FUNCTIONAL INSPECTION OF THE PRODUCT INVOLVED IN THE COMPLAINT COULD NOT BE CONDUCTED SINCE THE PRODUCT WAS NOT RETURNED. THE DEVICE HISTORY RECORD (DHR) FOR THE REPORTED LOT NUMBER WAS REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. NO NON CONFORMANCE REPORTS WERE ORIGINATED FOR THE REPORTED LOT NUMBER THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. PRODUCT IFU DOCUMENT REVIEWED. THE PRODUCT IFU STATES SEVERAL WARNINGS IN ORDER TO AVOID OVERHEATING THE CIRCUIT AND INSTRUCTIONS FOR USE OF THE PRODUCT. THE CUSTOMER COMPLAINT WAS NOT CONFIRMED DUE TO THE LACK OF THE SAMPLE AT THE TIME OF THIS REPORT. HOWEVER, BASED ON THE CUSTOMER COMPLAINT DESCRIPTION THE PRODUCT WAS USED AGAINST IFU WARNINGS.

    Description of Event or Problem · 1

    THE COMPLAINT WAS REPORTED AS: THE CUSTOMER REPORTS THAT THE NURSING PERSONNEL HAD TO TURN OFF THE NEPTUNE DUE TO ALARM AND DISCOVERED MELTED TUBING LEAVING THE CONCHA COLUMN. ALSO DISCOVERED A LOT OF RAINOUT ON THE INSPIRATORY TUBE LINE. THEY REPLACED THE VENTILATOR AND NEPTUNE WHICH WORKED FINE. UPON EXAMINATION (BY BIOMED AND TELEFLEX SALES REP). IT WAS DISCOVERED THAT THE 780-35 WAS SET UP INCORRECTLY BY RESPIRATORY CARE PERSONNEL. THE INSPIRATORY LINE TUBE WAS INCORRECTLY CONNECTED TO THE EXPIRATORY OUTLET ON THE VENTILATOR. THE EXPIRATORY TUBE LINE WAS INCORRECTLY CONNECTED TO THE TOP OF THE CONCHA COLUMN. SINCE THERE IS NO TEMP PORT AVAILABLE FOR THE SHORT PROBE, IT WAS LEFT IN OPEN AIR. THE HEATER CABLES WERE CONNECTED CORRECTLY. NO REPORT OF PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211842 HUDSON ADULT HEATED WIRE CIRCUIT DUAL LIMB HEATED WIRE CIRCUIT CAI TELEFLEX MEDICAL 02C1302414

    Patients

    Seq Age Sex Outcome Treatment
    1 VENTILATOR| NEPTUNE HEATER