BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIVONA TRACH PEDS 3.5

    MDR report key: 6459714 · Received April 5, 2017

    Report

    Report Number
    6459714
    Event Type
    Malfunction
    Date Received
    April 5, 2017
    Date of Event
    March 15, 2017
    Report Date
    March 30, 2017
    Manufacturer
    SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
    Product Code
    JOH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PT NOTED TO HAVE SIGNIFICANT INCREASED LEAK ON VENT; RT (RESPIRATORY THERAPY) TO BEDSIDE, TRACH CUFF NOTED TO BE LEAKING AS WATER REMOVED TO VERIFY (0.5ML) DID NOT EQUAL AMOUNT THAT HAD BEEN PLACED INTO CUFF (3ML). NNP (NEONATAL NURSE PRACTITIONER) NOTIFIED AND CALLED ENT TO NOTIFY THEM OF FINDINGS. RT ALSO NOTIFIED, NNP, RNX2, RT, DR. ENT AT BEDSIDE DECIDED TO CHANGE THE TRACH; AFTER TIES WERE REMOVED WITHOUT OTHER MANIPULATION, PT BEGAN DECOMPENSATING. NNP BEGAN BAGGING WITH INO AND MINIMAL CHEST WALL MOVEMENT NOTED. HR AND SPO2 CONTINUED TO DECREASE. RN STARTED COMPRESSIONS WHICH WERE AROUND 20 SECONDS TO LESS THAN 1 MINUTE WITH NNP PPV. THE PT HAD A BRONCHOSPASM, ALBUTEROL GIVEN VIA TRACH W/CONTINUED BAGGING. PT STABILIZED AND TRACH CHANGED WITHOUT DIFFICULTY. SENT FOR REVIEW BY ENT CHIEF. PER FELLOW THE PT HAD THIS ISSUE PREVIOUS TO THE TRACH CUFF ISSUE, HAS HAD PAST DESATS AND ALBUTEROL, PT RESPONDED AND STABILIZED QUICKLY, CHANGED OUT THE TRACH ONCE PT STABLE, THERE WERE NO ISSUES WHEN CHANGED TRACH , DID WELL, WAS UNEVENTFUL. TUBE DEFECT PER ENT FELLOW COULD NOT BE DETERMINED TO BE THE CAUSE OF THE BRONCHOSPASM, PT HAD HX OF BRONCHOSPASMS AND NEED FOR ALBUTEROL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    242600 BIVONA TRACH PEDS 3.5 TUBE, TRACHEOSTOMY JOH SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR