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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE

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ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT BZE Back to Search Results
Model Number RT380
Device Problem Obstruction of Flow (2423)
Patient Problems Increased Peak Expiratory Flow rate (2436); Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)
Event Date 08/16/2021
Event Type  Injury  
Event Description
A healthcare facility in (b)(6) reported, via a fisher & paykel healthcare (f&p) field representative, that a severely ill, mechanically ventilated trache patient on a rt380 adult dual heated evaqua2 breathing circuit experienced patient- ventilator asynchrony during nebulization of cyclokrapon (tranexamic acid). It was also reported that the patient desaturated to 75% spo2 levels with a sudden increase in peak inspiratory pressure(pip) and intrinsic peep(positive end-expiratory pressure). The nebulisation treatment was ceased and the intrinsic peep was "emptied" via mechanical chest compressions. The healthcare facility further reported that the filter on the expiratory limb was replaced and the subject circuit remained in use without any issues. There was no further reported patient consequence.
 
Manufacturer Narrative
(b)(4). Method: the complaint rt380 adult dual heated evaqua2 breathing circuit was not returned to fisher & paykel healthcare for evaluation. Our investigation is based on the information provided by the customer and our knowledge of the product. Results: the customer reported that a severely ill, mechanically ventilated trache patient on a rt380 adult dual heated evaqua2 breathing circuit experienced patient- ventilator asynchrony during nebulization of cyclokrapon (tranexamic acid). It was also reported that the patient desaturated to 75% spo2 levels with a sudden increase in peak inspiratory pressure(pip) and intrinsic peep(positive end-expiratory pressure). The nebulisation treatment was ceased and the intrinsic peep was "emptied" via mechanical chest compressions. The healthcare facility further reported that the filter on the expiratory limb was replaced and the subject circuit remained in use without any issues. The healthcare facility also confirmed that there was no observed physical damage on the subject circuit. Conclusion: without the return of the complaint device, we are unable to determine the root cause of the reported event. However, based on the assessment of the information provided it is likely that the reported incident occured due to the blockage of the expiratory filter. All rt380 adult evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected. The subject breathing circuit would have met the required specifications at the time of production. The user instructions that accompany the rt380 breathing circuit state the following: -"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 the gas flow) may result in serious harm, or death. " - "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient. " "failure to comply with the following warnings may impair performance of the device or compromise safety (including potentially cause serious harm): -change filter every 24 hours, or sooner if noticable deterioration/build-up occurs, following standard hospital procedure. Attention ensure appropriate ventilator or flow source alarms are set before connecting breathing set to the patient. When nebulized drugs are used, resistance to flow should be monitored, and filter replaced following standard hospital procedure. ".
 
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Brand NameADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of DeviceBZE
MDR Report Key12472129
MDR Text Key280479679
Report Number9611451-2021-01058
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial
Report Date 08/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/14/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberRT380
Device Catalogue NumberRT380
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/14/2021 Patient Sequence Number: 1
Treatment
AEROGEN SOLO NEBULIZER; DAR COVIDIEN CLOSED CIRCUIT; DRÄGER CO2 CELL; F&P MR850 RESPIRATORY HUMIDIFIER; F&P RT020 EXPIRATORY FILTER; SERVO U (MAQUET) VENTILATOR
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