BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PORTEX

    MDR report key: 10457016 · Received August 26, 2020

    Report

    Report Number
    3012307300-2020-08523
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    July 20, 2020
    Report Date
    October 2, 2020
    Manufacturer
    SMITHS MEDICAL INTERNATIONAL, LTD.
    Product Code
    BTO
    UDI-DI
    15019517076158
    PMA / PMN Number
    K173384
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: ONE USED DECONTAMINATED SAMPLE 10009163-004 8MM DEHT BLU SUCTIONAID SUB-ASSY 1/EA WAS RECEIVED IN PLASTIC BAG WITHOUT ITS ORIGINAL PACKAGING. HIGH PRESSURE WARNING OF VENTILATOR MIGHT BE ENABLED BECAUSE OF INCREASED OR THICKER MUCUS OR OTHER SECRETIONS BLOCKING THE AIRWAY. IT CAN HAPPEN WHEN SUCTIONING OF PATIENT AIRWAY IS NOT PROPERLY DONE. UNDER VISUAL INSPECTION OF RETURNED SAMPLE WE NOTICED THAT SUCTION CONNECTOR IS NOT PRESENT ON SUCTION LINE WHICH MIGHT CAUSE NOT EFFECTIVE SUCTIONING. AFFECTED SUCTION LINE IS MANUFACTURED IN SMITHS MEDICAL TIJUANA AND IS INSPECTED AS PER PWI-10008350 REV. 102. BONDING OF CONNECTOR WITH SUCTION LINE IS FUNCTIONALLY CHECKED AS PER CHAPTER 4 BOND OF TUBE TO CONNECTOR OF SUCTION LINE WITH FREQUENCY 16 SAMPLES AT THE START OF THE SHIFT AND EVERY HOUR DURING THE SHIFT. EACH TRACHEOSTOMY TUBE (INCLUDING SUCTION LINE WITH CONNECTOR) IS ALSO VISUALLY INSPECTED DURING TRACHEOSTOMY TUBE ASSEMBLY PROCESS WHICH IS DONE IN SMITHS MEDICAL CZECH REPUBLIC AS PER PWI-10011068, PWI-10011069, PWI-10011070 AND PWI-10011098. IT IS HIGHLY IMPROBABLE THAT SUCTION LINE WITHOUT CONNECTOR WOULD PASS THIS INSPECTION. BASED ON RESULTS OF THIS INVESTIGATION REPORTED ISSUE HAPPENED THE MOST PROBABLY BECAUSE OF NOT EFFECTIVE SUCTIONING DURING USE WHICH WAS CAUSED AS RESULT OF SUCTION CONNECTOR VS SUCTION LINE SEPARATION. ROOT CAUSE OF THIS SEPARATION REMAINS UNKNOWN. NO TREND OF SIMILAR CUSTOMER COMPLAINTS WAS IDENTIFIED.

    Description of Event or Problem · 1

    INFORMATION RECEIVED A SMITH MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT MALFUNCTIONED. DURING THE USE OF THE PRODUCT, A HIGH-PRESSURE WARNING ALARM KEPT SOUNDING. IT PERSISTED EVEN AFTER THE CUSTOMER PERFORMED A SUCTION OR ADJUSTED THE CUFF AIR PRESSURE. EVERY TIME THE ALARM WENT OFF, THE TIDAL WAVE LOWERED ACCORDINGLY. THE SPO2 VALUE DID NOT GO DOWN, BUT THE RESPIRATORY CONDITIONS OF THE PATIENT GOT WORSE. SO THE CUSTOMER REPLACED THE PRODUCT WITH A NON-SMITHS' ONE. AFTER THAT, THE SITUATION GOT BETTER. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    917921 PORTEX TRACHEOSTOMY BTO SMITHS MEDICAL INTERNATIONAL, LTD. 101/860/080CZ 15019517076158

    Patients

    Seq Age Sex Outcome Treatment
    1