BEUDAMED
    FDA Adverse Event Death Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 11639470 · Received April 9, 2021

    Report

    Report Number
    9611451-2021-00375
    Event Type
    Death
    Date Received
    April 9, 2021
    Date of Event
    January 20, 2021
    Report Date
    March 12, 2021
    Product Code
    BTT
    UDI-DI
    09420012430311
    PMA / PMN Number
    K983112
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS REQUESTED, HOWEVER WAS NOT RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. ADDITIONAL INFORMATION WITH REGARDS TO THE REPORTED EVENT AND PATIENT OUTCOME WAS ALSO REQUESTED FROM THE HOSPITAL, HOWEVER LIMITED INFORMATION WAS PROVIDED. THEREFORE, OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: IT WAS REPORTED THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT BECAME UNINTENTIONALLY DISCONNECTED FROM THE BIPAP MASK. IT WAS FURTHER REPORTED THAT THE CIRCUIT WAS RECONNECTED TO THE FILTER INSTEAD OF THE BIPAP MASK. IT WAS REPORTED THAT THE PATIENT WAS BEING TREATED FOR COVID-19 AND LHAS SINCE PASSED AWAY. CONCLUSION: THE REPORTED RECONNECTION OF THE CIRCUIT TO THE FILTER INSTEAD OF THE BIPAP MASK WAS A RESULT OF USER ERROR. THERE WAS NO REPORTED DAMAGE OR MALFUNCTION WITH THE RT219 BREATHING CIRCUIT. THE USER INSTRUCTIONS THAT ACCOMPANY THE RT219 BI-LEVEL/CPAP BREATHING CIRCUIT INCLUDE A PICTORIAL SHOWING THE INSTRUCTIONS TO CONNECT THE CIRCUIT AND EXHALATION PORT CORRECTLY. IT ALSO INCLUDES THE FOLLOWING: CHECK ALL CONNECTIONS ARE TIGHT BEFORE USE. APPROPRIATE PATIENT MONITORING (E.G. OXYGEN SATURATION) MUST BE USED AT ALL TIMES. FAILURE TO MONITOR THE PATIENT (E.G. IN THE EVENT OF AN INTERRUPTION TO GAS FLOW) MAY RESULT IN SERIOUS HARM OR DEATH. ENSURE APPROPRIATE VENTILATOR OR FLOW SOURCE ALARMS ARE SET BEFORE CONNECTING BREATHING SET TO PATIENT. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. FOR USE UNDER THE SUPERVISION OF TRAINED MEDICAL PERSONNEL.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN WISCONSIN REPORTED THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT BECAME UNINTENTIONALLY DISCONNECTED FROM THE BIPAP MASK. IT WAS FURTHER REPORTED THAT THE CIRCUIT WAS RECONNECTED TO THE FILTER INSTEAD OF THE BIPAP MASK. THE PATIENT WAS IN COVID ISOLATION AND HAS SINCE PASSED AWAY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINT (B)(4) ADULT BI-LEVEL/CPAP BREATHING CIRCUIT IS EXPECTED, BUT HAS NOT YET RETURNED TO FISHER & PAYKEL HEALTHCARE (F&P) IN (B)(6) FOR INVESTIGATION TO DETERMINE IF OUR PRODUCT CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED THAT THE (B)(4) ADULT BI-LEVEL/CPAP BREATHING CIRCUIT DISCONNECTED FROM THE BIPAP MASK. THE STAFF MEMBER THEN INCORRECTLY RECONNECTED THE CIRCUIT TO THE FILTER INSTEAD OF THE MASK. THE PATIENT HAS SINCE PASSED AWAY. WE HAVE REQUESTED FURTHER INFORMATION FROM THE HEALTHCARE FACILITY TO BETTER UNDERSTAND THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537485 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT RT219 2100863667 09420012430311

    Patients

    Seq Age Sex Outcome Treatment
    1 Death HEM FILTER| HEM FILTER| PHILLIPS V60 BIPAP MASK| PHILLIPS V60 BIPAP VENTILATOR| RESPIRONICS M AF541 MASK| RESPIRONICS M AF541 MASK| HEM FILTER| PHILLIPS V60 BIPAP MASK| RESPIRONICS M AF541 MASK