MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT; BTT

Model Number 900MR782

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The 900mr782 reusable neonatal single heated breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k913368.We are currently in the process of obtaining further information from the hospital to determine if the complaint 900mr782 reusable neonatal single heated breathing circuits caused or contributed to the reported event.We will provide a follow up report once we have completed our evaluation.

Event Description

A hospital in (b)(6) reported via our distributor that their reusable circuits started showing small holes with air leaks and also some parts of them presented stretched out areas.These circuits were used for some time and were sterilized.In this reported event, two complaint 900mr782 reusable neonatal single heated breathing circuits apparently presented small holes and stretched areas.One circuit was used on a patient, who desaturated, but fully recovered.No further patient consequence was reported.

Manufacturer Narrative

The 900mr782 reusable neonatal single heated breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k913368.The customer reported two complaint 900mr782 reusable infant breathing circuits, but three lot numbers were provided, as the customer could not determine which lot numbers were the affected ones: 1x lot number 140409 (manufactured on 9 april 2014), 1x lot number 140612 (manufactured on 12 june 2014) and 1x lot number 140807 (manufactured on 7 august 2014).The complaint 900mr782 reusable infant breathing circuits were not returned to fisher & paykel healthcare (b)(4) for investigation.A photograph of one complaint circuit was provided by the customer.Therefore, our investigation is based on the information provided by the customer, the investigation of the provided photograph, previous similar investigations and our knowledge of the product.Results: the customer reported that the tubing on the 900mr782 reusable infant breathing circuits showed small holes and was leaking and some parts of the circuit were stretched out.The customer further noted that the used sterilization process is "sterrad nx, 60°c, 45-50min, with hydrogen peroxide".The sterrad process uses greater than 50% hydrogen peroxide solution at temperatures of about 55°c to achieve sterilisation.Visual inspection of the provided photograph revealed that the circuit was stretched and had holes.Conclusion: we are unable to determine what may have caused the damage noted on the 900mr782 reusable infant breathing circuits.However, based on the photograph provided, it is possible that the subject breathing circuits have been stretched.It is also likely that the use of a sterrad disinfection process, which is not listed as a recommended disinfection method in the user instruction, and the extended time the breathing circuits were inside the autoclave have contributed to the reported damage.All reusable infant breathing circuits are leak tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported faults occurred after the subject breathing circuits were released for distribution.The user instructions that accompany the 900mr782 reusable infant breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient.Set appropriate ventilator alarms.Inspect circuit components for damage before reassembly.Clean all circuit components before use and after each patient use using approved disinfection methods only.Additionally, the user instructions that accompany the 900mr782 reusable infant breathing circuit describe the approved disinfection methods: approved disinfection methods: autoclave 132°c (270°f) @ 220 kpa (32 psi) for 4 minutes; autoclave 121°c (250°f) @ 96 kpa (14.1 psi) for 30 minutes; ethylene oxide: 55°c (131°f).

Event Description

A hospital in (b)(6) reported via our distributor that their reusable circuits started showing small holes with air leaks and also some parts of them presented stretched out areas.These circuits were used for some time and were sterilized.In this reported event, two complaint 900mr782 reusable neonatal single heated breathing circuits apparently presented small holes and stretched areas.One circuit was used on a patient, who desaturated, but fully recovered.No further patient consequence was reported.

• Brand Name: REUSABLE NEONATAL SINGLE HEATED BREATHING CIRCUIT
• Type of Device: BTT
• 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: jonathan stevens ; 173 technology dr., suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6320906
• MDR Text Key: 67331404
• Report Number: 9611451-2017-00078
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2017

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 Number: 900MR782
• Device Catalogue Number: 900MR782
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/12/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/09/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1