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

Model Number	RT385
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).We are currently in the process of completing our investigation.We will provide a follow up report upon completion of our investigation.
Event or Problem Description
A healthcare facility in brazil reported via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that a mr290v vented autofeed humidification chamber was found leaking water during patient use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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 subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: - "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." - "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." - "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure.".
Event or Problem Description
A healthcare facility in brazil reported via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water during patient use.There was no reported patient consequence.
Event or Problem Description
A healthcare facility in brazil reported via a fisher and paykel healthcare (f&p) field representative, that a mr290v vented autofeed humidification chamber was found leaking water during patient use.There was no reported patient consequence.
Additional Manufacturer Narrative
(b)(4).Udi related data quality updates only.Corrections to reflect gudid: section d1: brand name updated to fisher & paykel healthcare.Section d2a: common device name updated to breathing circuit.Section d2b: product code update to bze.Section d4: model and catalog # updated to rt385.Section d4: expiration date added.Section d4: udi details updated.Section g1: contact person updated to (b)(4).Section g4: pma/510(k) number updated.Method: the complaint mr290v vented autofeed humidification chamber was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information provided by the customer and our knowledge of the product.Results: the healthcare facility reported that a mr290v vented autofeed humidification chamber was found leaking water during patient use.Conclusion: without the complaint device, we are unable to determine the cause of the reported event.The mr290v chambers are designed and tested to conform to iso 5367 breathing tubes intended for use with anaesthetic apparatus and ventilators.Every mr290v chamber is pressure tested following the manufacturing process to check for any leaks present in the chamber dome 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 subject mr290v chamber would have met the required specification at the time of production.Our user instructions that accompany the mr290v vented autofeed humidification chamber state the following: "do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers." "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." "use of the mr290 above the maximum operating pressure may lead to cracking, water leakage and, on rare occasions, could lead to a loss of ventilation pressure.".

• 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 vargas banuelos ; 17400 laguna canyon road; suite 300; irvine, CA 92618 ; 9494341005
• MDR Report Key: 17892703
• Report Number: 9611451-2023-00940
• Device Sequence Number: 20694743
• Product Code: BZE
• UDI-Device Identifier: 09420012430472
• UDI-Public: (01)09420012430472(10)2102526321(11)230222(17)280222
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K122432
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/04/2023
• 2 Devices were Involved in the Event: 1 2

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: RT385
• Device Catalogue Number: RT385
• Device Lot Number: 2102526321
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 10/16/2023; 10/16/2023
• Initial Report FDA Received Date: 10/08/2023
• Supplement Report FDA Received Date: 10/24/2023; 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/22/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: F&P RT385 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT385 ADULT EVAQUA2 BREATHING CIRCUIT; F&P RT385 ADULT EVAQUA2 BREATHING CIRCUIT
• Patient Sex: Unknown