BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALL BREATHING SYSTEM FILTER

    MDR report key: 315248 · Received February 7, 2001

    Report

    Report Number
    9680602-2000-00006
    Event Type
    Other
    Date Received
    February 7, 2001
    Date of Event
    November 13, 2000
    Report Date
    November 29, 2000
    Manufacturer
    PALL NEWQUAY, LTD.
    Product Code
    BYD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER THE ANESTHETIST HAD INTUBATED THE PT, WITH A SMALL LARYNGEAL AIRWAY, ANESTHETIST ATTACHED THE DEVICE AND AS ANESTHETIST CUSTOMARILY DOES, HAND BAGGED THE PT. ANESTHETIST NOTICED THAT THE PT WAS HARD TO BAG, AND DECIDED TO CHANGE THE AIRWAY MASK TO A LARGER SIZE, AS ANESTHETIST THOUGHT THE AIRWAY PIECE MIGHT HAVE BEEN TO SMALL FOR THE PT. ONCE AGAIN ANESTHETIST BAGGED THE PT AND STILL FELT IT WAS HARD TO DO, SO ANESTHETIST RE-INTUBATED THE PT WITH A SIZE 8 ET TUBE. BY THIS TIME, THE PT WAS DISPLAYING SIGNS OF HYPOVENTILATION, SLIGHT DROP IN O2 SATURATION AND RISE IN CO2. ANESTHETIST COMMENCED RESUSCITATION OF THE PT AS ANAPHYLAXIS (TO SOME ANESTHETIC MEDICATION) AND ADMINISTERED ADRENALIN IV AND CONTINUED BAGGING THE PT. THE PROCEDURE WAS CANCELLED, AND THE PT WAS TO BE TRANSFERRED TO ICU IMMEDIATELY, FOR CONTINUED RESUSCITATION AND STABILIZATION OF VENTILATION. AS THEY MOVED THE PT FROM THE BAG TEMPORARILY AND RECONNECTED THE PT TO THE TRANSPORT BLACK BAG AND CIRCUIT, THEY NOTICED AN IMMEDIATE IMPROVEMENT IN THE PT'S CONDITION, I.E., EASY TO BAG. THEY TEMPORARILY RECONNECTED THE PT TO THE BAG AND FILTER AND FOUND ONCE AGAIN IT WAS DIFFICULT TO VENTILATE. THE PT SPENT THE NIGHT IN THE ICU, MONITORED AND RETURNED FOR THE OPERATION THE NEXT DAY. THERE WERE NO PT SEQUELAE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4600 PALL BREATHING SYSTEM FILTER SMALL VOLUME HME EXCHANGER BYD PALL NEWQUAY, LTD. BB25S 99-1000/935401

    Patients

    Seq Age Sex Outcome Treatment
    1 0 * Required Intervention