MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LIMITED FISHER & PAYKEL HEALTHCARE; TUBING KIT

Model Number	RT330
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Low Oxygen Saturation (2477)
Date of Event	08/30/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A healthcare facility in canada reported via a fisher and paykel healthcare (f&p) field representative, that a patient was being assessed for unexplained desaturations (to 70% spo2).The patient was transferred to picu where it was identified that the maxtec oxygen analyser was leaking and " falling out frequently" when connected to the rt330 optiflow junior tubing kit.There was no patient harm reported.There were no further reported patient consequences.
Additional Manufacturer Narrative
(b)(4).We are currently in the process of obtaining further information about the reported event.We will provide a follow up report upon the completion of our investigation.
Additional Manufacturer Narrative
(b)(4) corrected data: section b1.Report type: adverse event section h1.Type of reportable event: serious injury method: the subject rt330 optiflow junior tubing kit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Results: the healthcare facility reported that there was a leakage from the connection between the maxtec oxygen analyser and the rt330 optiflow junior tubing kit.It was also reported that the maxtec oxygen analyser was falling out frequently.Conclusion: without the complaint device, we are unable to confirm if there was a fault with the rt330 optiflow junior tubing kit.All rt330 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject rt330 circuit would have met the required specification at the time of production.Our user instructions that accompany the rt330 optiflow junior tubing kit 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 gas flow) may result in serious harm or death." "visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use, and replace if damaged." "check all connections are tight before use." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.
Event or Problem Description
A healthcare facility in canada reported via a fisher and paykel healthcare (f&p) field representative, that a patient was being assessed for unexplained desaturations (to 70% spo2).The patient was transferred to picu where it was identified that there was a leakage and the maxtec oxygen analyser was falling out frequently when connected to the rt330 optiflow junior tubing kit.There was no patient harm reported.There were no further reported patient consequences.
Event or Problem Description
A healthcare facility in canada reported via a fisher and paykel healthcare (f&p) field representative, that a patient was being assessed for unexplained desaturations (to 70% spo2).The patient was transferred to picu where it was identified that there was a leakage and the maxtec oxygen analyser was falling out frequently when connected to the rt330 optiflow junior tubing kit.There was no patient harm reported.There were no further reported patient consequences.
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 tubing kit.Section d4: expiration date added.Section d4: udi details updated.Section g1: contact person updated to mr.(b)(6).Method: the subject rt330 optiflow junior tubing kit was not returned to fisher & paykel healthcare (f&p) in new zealand for investigation.Results: the healthcare facility reported that there was a leakage from the connection between the maxtec oxygen analyser and the rt330 optiflow junior tubing kit.It was also reported that the maxtec oxygen analyser was falling out frequently.Conclusion: without the complaint device, we are unable to confirm if there was a fault with the rt330 optiflow junior tubing kit.All rt330 circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.The subject rt330 circuit would have met the required specification at the time of production.Our user instructions that accompany the rt330 optiflow junior tubing kit 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 gas flow) may result in serious harm or death." "visually inspect breathing sets for damage (e.G.Crushed tube or cracked connector) before use, and replace if damaged." "check all connections are tight before use." "ensure appropriate ventilator or flow source alarms are set before connecting breathing set to patient.

• Brand Name: FISHER & PAYKEL HEALTHCARE
• Common Device Name: TUBING KIT
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 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: 17909864
• Report Number: 9611451-2023-00939
• Device Sequence Number: 6653296
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2102376641(11)221006(17)271006
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2102376641
• 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: 09/11/2023
• Supplement Date Received by Manufacturer: 10/31/2023; 10/31/2023
• Initial Report FDA Received Date: 10/10/2023
• Supplement Report FDA Received Date: 11/26/2023; 09/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/06/2022
• 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: INTERSURGICAL T-PIECE CONNECTOR; INTERSURGICAL T-PIECE CONNECTOR; INTERSURGICAL T-PIECE CONNECTOR; MAXTEC OXYGEN ANALYSER; MAXTEC OXYGEN ANALYSER; MAXTEC OXYGEN ANALYSER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown