BEUDAMED
    FDA Adverse Event Death Summary report: N

    PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE UNKNOWN MODEL

    MDR report key: 8971010 · Received September 6, 2019

    Report

    Report Number
    2024841-2019-00005
    Event Type
    Death
    Date Received
    September 6, 2019
    Report Date
    September 6, 2019
    Manufacturer
    PASSY-MUIR INC.
    Product Code
    JOH
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT DID NOT INVOLVE A MALFUNCTION OF THE PASSY-MUIR VALVE. THE RESPIRATORY SPECIALIST FAILED TO FOLLOW THE MANUFACTURER'S INSTRUCTIONS FOR VENTILATOR APPLICATION WITH THE PASSY-MUIR VALVE. THE VENTILATOR ALARMS WERE NOT SET PROPERLY FOR PASSY-MUIR VALVE USE SPECIFICALLY THE LOW AND HIGH PRESSURE ALARMS. WHEN THE DISCONNECTION OCCURRED, THERE WERE NO ALARMS SOUNDING TO ALERT CAREGIVERS TO DISCONNECTION. BECAUSE OF OUR DESIRE TO PROVIDE VALVES THAT ARE BOTH SAFE AND EFFECTIVE, EACH VALVE UNDERGOES RIGOROUS TESTING PROCEDURES INCLUDING INSPIRATORY OPENING PRESSURES, POSITIVE CLOSURE TESTING, STRESS TESTING, ETC. FURTHER, IT IS WRITTEN IN THE INSTRUCTION BOOKLET THAT FAILURE TO RE-EVALUATE AND ADJUST VENTILATOR ALARMS MAY COMPROMISE PATIENT SAFETY. HIGH AND LOW PRESSURE SETTINGS ON THE VENTILATOR MUST BE REASSESSED AT THIS TIME TO ENSURE PATIENT SAFETY. AS THE MANUFACTURER OF THE PASSY-MUIR VALVE, WE TAKE SPECIAL CARE TO PACKAGE EVERY VALVE WITH A COMPREHENSIVE CLINICAL INSTRUCTION BOOKLET, PATIENT HANDBOOK AND CAUTION LABELS.

    Description of Event or Problem · 1

    ON 08/07/2019, THE COMPANY LEARNED OF AN OFFICE OF INSPECTOR GENERAL (OIG) REPORT (REPORT # (B)(4) DATED JULY 30, 2019). THE OIG REPORT STATES, "ON THE MORNING OF PATIENT A'S DEATH, THE ASSIGNED RESPIRATORY THERAPIST PLACED AN IN-LINE PASSY-MUIR® VALVE (PMV) ON THE VENTILATOR TO ALLOW PATIENT A TO COMMUNICATE WITH A FAMILY MEMBER. THE RESPIRATORY THERAPIST LOWERED OR DISABLED THE VENTILATOR ALARMS SO THAT THEY WOULD NOT CONSTANTLY SOUND. THE FAMILY MEMBER AND AN SCI NURSE WERE PRESENT IN THE ROOM WHEN THE RESPIRATORY THERAPIST LEFT. SOMETIME AROUND 8:00AM, THE FAMILY MEMBER LEFT TO GO TO WORK. NURSING STAFF INTERACTED WITH PATIENT A ON THREE SEPARATE OCCASIONS BETWEEN ABOUT 10:00AM AND 12:00PM. WHEN THE NURSE RETURNED AT 12:10PM, PATIENT A WAS UNRESPONSIVE IN BED WITH THE VENTILATOR TUBE DISCONNECTED FROM THE TRACHEOSTOMY AND NO VENTILATOR ALARMS SOUNDING ... PATIENT A DID NOT SURVIVE." THE CONCLUSION IN THE OIG REPORT STATES, "THE ASSIGNED RESPIRATORY THERAPIST TURNED THE VENTILATOR CLINICAL ALARMS EITHER LOW OR OFF AFTER PLACING THE IN-LINE PMV ON PATIENT A. RESPIRATORY THERAPY SUPERVISORS AND STAFF STATED THIS WAS NOT AN UNREASONABLE PRACTICE. HOWEVER, PER THE PMV MANUFACTURER'S INSTRUCTIONS, WHILE SOME ALARMS CAN BE DEACTIVATED, THE HIGH- AND LOW- PRESSURE ALARMS SHOULD REMAIN ACTIVE TO ALERT CAREGIVERS TO DISCONNECTS, PATIENT FATIGUE, OR OTHER CLINIC ISSUES".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762765 PASSY-MUIR TRACHEOSTOMY VENTILATOR SWALLOWING AND SPEAKING VALVE UNKNOWN MODEL TRACHEOSTOMY SPEAKING VALVE JOH PASSY-MUIR INC. UNKNOWN PMV UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Death CAREFUSION LTV 1150 MODEL VENTILATOR