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

Model Number RT268

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Pma/510(k): the rt268 infant dual heated evaqua2 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 k103767.Manufacturer narrative we are currently in the process of obtaining the complaint rt268 infant dual heated evaqua2 breathing circuit from the hospital for investigation to determine if it had a malfunction, which could have caused or contributed to the reported event.We will provide a follow up report once we have completed our investigation.

Event Description

A hospital in the (b)(6) reported that the swivel connector of an rt268 infant dual heated evaqua2 breathing circuit was cracking and falling apart.This was observed during use on a patient.It was also reported that the crack caused a big leak on the ventilator, affecting the pressure delivery.No patient harm was reported.

Manufacturer Narrative

(b)(4).Pma/510(k) the rt268 infant dual heated evaqua2 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 k103767.Method: the complaint rt268 infant dual heated evaqua2 breathing circuit was returned to fph (b)(6) for inspection.It was visually inspected and pressure tested for leaks.Results: visual inspection revealed a crack along one of the swivel wye ports.Further damage was also observed around the cracked area.The pressure test result was outside of the specification.Conclusion: investigations into this issue have determined that the cracking has most likely occurred due to improperly mixed material in the batch.We have since contacted the supplier and arranged for them to supply the molding material with the two parts already mixed.We anticipate that this will resolve the issue and the project to implement this change is scheduled next month.All rt268 infant dual heated evaqua2 breathing circuits are visually inspected and pressure and flow tested during production, and those that fail are rejected.Our user instructions that accompany the rt268 infant dual heated evaqua2 breathing circuit state the following: "check all connections are tight before use." "perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient." "set appropriate ventilator alarms.".

Event Description

A hospital in (b)(6) reported that the swivel connector of an rt268 infant dual heated evaqua2 breathing circuit was cracking and falling apart.This was observed during use on a patient.It was also reported that the crack caused a big leak on the ventilator, affecting the pressure delivery.No patient harm was reported.

• Brand Name: INFANT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• Manufacturer (Section D): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer (Section G): FISHER & PAYKEL HEALTHCARE LIMITED; 15 maurice paykel place; east tamaki; auckland, auckland 2013 ; NZ 2013
• Manufacturer Contact: sharon kuruvilla ; 173 technology dr., suite 100; irvine; 9494534000
• MDR Report Key: 6723838
• MDR Text Key: 80417069
• Report Number: 9611451-2017-00651
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2017

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: RT268
• Device Catalogue Number: RT268
• Device Lot Number: NOT PROVIDED.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/23/2017
• Initial Date FDA Received: 07/18/2017
• Supplement Dates Manufacturer Received: 06/23/2017
• Supplement Dates FDA Received: 09/27/2017
• 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