MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD FISHER & PAYKEL HEALTHCARE; BREATHING CIRCUIT

Model Number	RT330
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The subject device mr290v vented autofeed humidification chamber has been requested to be returned to fisher & paykel healthcare in new zealand for evaluation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that an mr290v vented autofeed humidification chamber, provided as part of an rt330 optiflow tubing kit, was found leaking water prior to patient use.There was no patient involvement.
Event or Problem Description
A distributor reported on behalf of a healthcare facility in japan that an mr290v vented autofeed humidification chamber, provided as part of an rt330 optiflow tubing kit, was found leaking water prior to patient use.There was no patient involvement.
Additional Manufacturer Narrative
(b)(4).Correction: section d4: udi details updated.H11: method: the subject rt330 optiflow tubing kit was returned to f&p healthcare in new zealand, where it was visually inspected.Results: visual inspection of the returned device confirmed a crack at the bottom of the dome of the mr290v humidification chamber.Additionally, a horizontal scratch and stress whitening were observed near the crack.Conclusion: the cause of the reported water leak is due to the crack at the bottom of the chamber dome.The scratch and the stress whitening indicate that the chamber was most likely exposed to an external mechanical force.Every mr290 chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber due to cracks and other causes.Any chamber which fails this test is rejected.In addition, the pressure test is followed by a visual inspection of each chamber.No cracks in the chamber dome are acceptable.Any chamber that fails this inspection is rejected.The user instructions that accompany the rt330 optiflow tubing kit state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "do not use the chamber if the seals are not intact when received, or if it has been dropped." "visually inspect breathing sets for damage (e.G.A crushed tube or cracked connector) before use, and replace if damaged." "ensure appropriate ventilator and flow source alarms are set before connecting breathing set to patient.".

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: BREATHING CIRCUIT
• 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: diego banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 20001612
• Report Number: 9611451-2024-00606
• Device Sequence Number: 20662696
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2102926716(11)231218(17)281218
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K020332
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

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
• Operator of Device: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2102926716
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 08/20/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown