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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE
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FISHER & PAYKEL HEALTHCARE LTD INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE Back to Search Results
Model Number RT265
Device Problem Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2022
Event Type  malfunction  
Event Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that a rt265 infant dual-heated evaqua2 breathing circuit was found cracked during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).The complaint rt265 infant dual-heated evaqua2 breathing circuit is currently en route to fisher & paykel healthcare (f&p) for evaluation.We will provide a follow up report upon completion of investigation.
 
Event Description
A distributor reported on behalf of a healthcare facility in japan via a fisher & paykel healthcare (f&p) field representative, that a rt265 infant dual-heated evaqua2 breathing circuit was found cracked during use.There was no reported patient consequence.
 
Manufacturer Narrative
(b)(4).Method: the complaint rt265 infant dual-heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) in new zealand for evaluation, where it was visually inspected and analysed.Results: visual inspection of the returned complaint device revealed that the evaqua2 tube was found degraded.Fourier-transform infrared spectroscopy (ftir) analysis was performed and results show clear signs of hydrolysis.Hydrolysis can be caused by exposure to incompatible chemicals or steam.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that the reported event occurred due to the evaqua2 limb being exposed to chemical attack.All rt265 infant dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production and those that fail are rejected.The subject circuit would have met the required specifications at the time of production.The user instructions that accompany the rt265 infant dual-heated evaqua2 breathing circuit state: "do not soak, wash, sterilize or reuse this product.Avoid contact with chemicals, cleaning agents or hand sanitizers." "do not use medications containing tyloxapol (such as tacholiquin) as this may damage the tubing and lead to a loss of ventilation pressure." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.".
 
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Brand Name
INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
Type of Device
BZE
Manufacturer (Section D)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ  2013
Manufacturer (Section G)
FISHER & PAYKEL HEALTHCARE LTD
15 maurice paykel place
east tamaki
auckland, 2013
NZ   2013
Manufacturer Contact
faranak gomarooni
17400 laguna canyon road
suite 300
irvine, CA 92618
9494534000
MDR Report Key15992880
MDR Text Key305705513
Report Number9611451-2022-01189
Device Sequence Number1
Product Code BZE
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K103767
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative,Distributor
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 12/13/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberRT265
Device Catalogue NumberRT265
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 12/13/2022
Initial Date FDA Received12/15/2022
Supplement Dates Manufacturer Received04/20/2023
Supplement Dates FDA Received04/27/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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