BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT

    MDR report key: 10833969 · Received November 12, 2020

    Report

    Report Number
    9611451-2020-00997
    Event Type
    Malfunction
    Date Received
    November 12, 2020
    Report Date
    October 16, 2020
    Product Code
    BTT
    PMA / PMN Number
    K983112
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). METHOD: THE COMPLAINT DEVICE WAS NOT AVAILABLE FOR RETURN TO FISHER & PAYKEL HEALTHCARE (F&P) FOR EVALUATION. F&P HAVE REQUESTED FURTHER INFORMATION REGARDING THE REPORTED EVENT, HOWEVER LIMITED INFORMATION WAS PROVIDED. OUR INVESTIGATION IS BASED ON THE INFORMATION PROVIDED BY THE HOSPITAL AND OUR KNOWLEDGE OF THE PRODUCT. RESULTS: THE HOSPITAL REPORTED THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT DISCONNECTED FROM THE RESPIRONICS AF541 NON-INVASIVE VENTILATION (NIV) MASK. THE HOSPITAL NOTED THAT IT IS POSSIBLE THAT THE TUBING OF THE RT219 BREATHING CIRCUIT WAS ACCIDENTALLY PULLED OR SUBJECTED TO TENSION. IT WAS FURTHER REPORTED THAT THE VENTILATOR GENERATED AN ALARM, ALERTING THE CLINICIAN. THE CLINICIAN THEN INCORRECTLY RECONNECTED THE NIV MASK TO THE EXHALATION PORT INSTEAD OF THE EXHALATION PORT ADAPTOR. THE PATIENT BECAME HYPOXIC AND EXPERIENCED RESPIRATORY DISTRESS. THE NIV SETTINGS WERE INCREASED AND THE SET-UP WAS CORRECTED. THE PATIENT RECOVERED TO THE BASELINE CONDITION PRIOR TO THE EVENT. THE PATIENT HAS SINCE RECOVERED AND BEEN DISCHARGED FROM THE HOSPITAL. CONCLUSION: WITHOUT THE RETURN OF THE SUBJECT DEVICE, WE ARE UNABLE TO DETERMINE THE CAUSE OF THE DISCONNECTION, HOWEVER IT IS POSSIBLE DISCONNECTION OCCURRED DUE TO BEING SUBJECTED TO TENSION. THE REPORTED MISCONNECTION OF THE EXHALATION PORT TO THE NIV MASK WAS AS A RESULT OF USER ERROR. FURTHERMORE, THERE WAS NO REPORTED DAMAGE OR MALFUNCTION WITH THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT. THE HOSPITAL HAS SINCE PROVIDED FURTHER COMMUNICATION TO STAFF REGARDING THE CORRECT SET-UP OF NIV MASKS TO THE EXHALATION PORT OF THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT. ALL RT219 BREATHING CIRCUITS ARE VISUALLY INSPECTED AND PRESSURE AND FLOW TESTED DURING PRODUCTION, AND THOSE THAT FAIL ARE REJECTED. 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: DO NOT BLOCK OR SEAL THE VENT HOLES ON THE EXHALATION PORT. 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. EXHALATION PORT MUST BE USED WITH A NON-VENTED INTERFACE ON A SINGLE LIMB SYSTEM. FAILURE TO COMPLY MAY LEAD TO PATIENT INHALING EXCESS CARBON DIOXIDE RESULTING IN HYPERCAPNIA. PERFORM A PRESSURE AND LEAK TEST ON THE BREATHING SYSTEM AND CHECK FOR OCCLUSIONS BEFORE CONNECTING TO A PATIENT. DO NOT STRETCH OR MILK THE TUBING.

    Description of Event or Problem · 0

    A HEALTHCARE FACILITY IN MISSOURI REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT AS PART OF A NON-INVASIVE VENTILATION (NIV) SYSTEM DISCONNECTED FROM THE NIV MASK. THE CLINICIAN THEN INCORRECTLY RECONNECTED THE NIV MASK TO THE EXHALATION PORT. THE PATIENT BECAME HYPOXIC AND EXPERIENCED RESPIRATORY DISTRESS. THE NIV SETTINGS WERE INCREASED AND THE SET-UP WAS CORRECTED. THE PATIENT RECOVERED TO THE BASELINE CONDITION PRIOR TO THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Additional Manufacturer Narrative · 1

    (B)(4). WE ARE CURRENTLY IN THE PROCESS OF OBTAINING FURTHER INFORMATION AND THE COMPLAINT DEVICE FROM THE CUSTOMER FOR FURTHER EVALUATION. WE WILL PROVIDE A FOLLOW-UP REPORT UPON COMPLETION OF OUR INVESTIGATION.

    Description of Event or Problem · 1

    A HEALTHCARE FACILITY IN (B)(6) REPORTED VIA A FISHER & PAYKEL HEALTHCARE (F&P) FIELD REPRESENTATIVE THAT THE RT219 ADULT BI-LEVEL/CPAP BREATHING CIRCUIT AS PART OF A NON-INVASIVE VENTILATION (NIV) SYSTEM DISCONNECTED FROM THE NIV MASK. THE CLINICIAN THEN INCORRECTLY RECONNECTED THE NIV MASK TO THE EXHALATION PORT. THE PATIENT BECAME HYPOXIC AND EXPERIENCED RESPIRATORY DISTRESS. THE NIV SETTINGS WERE INCREASED AND THE SET-UP WAS CORRECTED. THE PATIENT RECOVERED TO THE BASELINE CONDITION PRIOR TO THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT FULLY RECOVERED AND WAS DISCHARGED FROM THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298995 BI-LEVEL/CPAP INSPIRATORY HEATED CIRCUIT BTT BTT RT219 NOT PROVIDED

    Patients

    Seq Age Sex Outcome Treatment
    1 RESPIRONICS AF541 MASK