MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problem Material Split, Cut or Torn (4008)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

A distributor in south africa reported that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.There was no patient involvement.

Manufacturer Narrative

Ps405375, ps405376, ps405415, ps405418.Device 1: lot#: 2101755702; date of manufacturing: 10-aug-2021; udi: (b)(4).Device 2: lot#: 2101486196; date of manufacturing: 28-jan-2021; udi: (b)(4).Device 3: lot#: 2101526223; date of manufacturing: 25-feb-2021; udi: (b)(4).Device 4: lot#: 2101502344; date of manufacturing: 10-feb-2021; udi: (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 Description

A distributor reported on behalf of a healthcare facility in south africa that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.There was no patient involvement.

Manufacturer Narrative

(b)(4).Section d4 and h4: device 1: lot#: 2101755702; date of manufacturing: 10-aug-2021; udi: (b)(4).Device 2: lot#: 2101486196; date of manufacturing: 28-jan-2021; udi: (b)(4).Device 3: lot#: 2101526223; date of manufacturing: 25-feb-2021; udi: (b)(4).Device 4: lot#: 2101502344; date of manufacturing: 10-feb-2021; udi: (b)(4).Corrected data: section b5.A distributor reported on behalf of a healthcare facility in south africa that the tubing of four rt380 adult dual heated evaqua2 breathing circuits were found damaged before use.Section e1.Name and address: (b)(6).Method: the complaint rt380 adult dual heated evaqua2 breathing circuits were received at fisher & paykel healthcare (f&p) in new zealand for evaluation, where they were visually inspected and analysed.Results: visual inspection of the returned rt380 adult dual heated evaqua2 breathing circuits revealed that the tubing were found degraded.Further analysis of the subject rt380 circuits using fourier-transform infrared spectroscopy (ftir) revealed that results were consistent with uv exposure causing material degradation.Conclusion: we are unable to determine the cause of the reported event.However, it is likely that the reported event occurred due to the tube being exposed to excessive uv light for a longer period of time.All rt380 adult dual-heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production and those that fail are rejected.The subject circuits would have met the required specifications at the time of production.The user instructions that accompany the rt380 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.".

• Brand Name: ADULT 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 Key: 15422726
• MDR Text Key: 306434346
• Report Number: 9611451-2022-00853
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 09/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/07/2023
• 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 Number: 1