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

Model Number RT266

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: three rt266 infant dual-heated evaqua2 breathing circuits and one rt266 expiratory limb were returned to fisher & paykel healthcare in (b)(4) for evaluation.The returned breathing circuits were visually inspected and the expiratory limb was also subjected to a water bath test.Results: visual inspection of the three breathing circuits revealed pin holes in all three inspiratory limbs and the proximal connectors on the three expiratory limbs were cracked.On one of the expiratory limbs the distal connector was also cracked.Visual inspection of the individual expiratory limb revealed that both the proximal and distal connectors were cracked.The hospital further reported that the circuits were used between 3-30 days and it was possible for the tubing to have been accidentally pulled.A lot check could not be carried out as the lot information was not provided by the hospital.Conclusion: we are unable to determine what may have caused the damage observed on the returned devices.However, the cracking noted on the expiratory limb connectors may have occurred as a result of the connectors coming into contact with cleaning chemicals or hand sanitizers.Using the circuits for longer than 7 days and pulling on the circuit may have also contributed to the observed damage.All infant breathing circuits are visually inspected and pressure and flow tested prior to being released for distribution.Any circuits that fail are rejected.This suggests the reported damage occurred after the circuits were released for distribution.The user instructions that accompany the rt266 infant evaqua2 breathing circuit state the following: "this product is to be used for a maximum of 7 days." "do not stretch or milk the tubing." "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" "do not soak, wash, sterilise or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers".

Event Description

A hospital in st petersburg, florida, reported to a fisher & paykel healthcare (fph) representative that the rt266 infant dual-heated evaqua breathing circuit has pin holes in the inspiratory limb.No patient consequence was reported.

• Brand Name: INFANT 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: raymond yan ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 5171552
• MDR Text Key: 29359685
• Report Number: 9611451-2015-00442
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT266
• Device Catalogue Number: RT266
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2015
• 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