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

Model Number RT330

Device Problem Occlusion Within Device (1423)

Patient Problem No Patient Involvement (2645)

Event Date 03/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the complaint rt330 optiflow junior tubing kit was returned to fisher & paykel healthcare in (b)(4) for investigation.The complaint rt330 optiflow junior tubing kit was visually inspected.Results: visual inspection revealed that the patient end connector was occluded.Conclusion: the patient end connector was occluded due to a moulding defect.Our investigation has revealed that the patient end connector is a supplied part.Our supplier quality team have been informed of the details of this investigation and will carry out an investigation with the supplier.We have only received one complaint of this nature.The user instructions that accompany the rt330 optiflow junior tubing kit state the following: - check all connections, caps and/or plugs are tight before use - patient monitoring is recommended.

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare (fph) field representative that the patient end connector of the rt330 optiflow junior tubing kit had an occlusion.There was no patient involvement.

• Brand Name: OPTIFLOW JUNIOR TUBING KIT
• Type of Device: BTT
• 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; 2013 ; NZ 2013
• Manufacturer Contact: irfanali kermalli ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 6756174
• MDR Text Key: 81504656
• Report Number: 9611451-2017-00632
• Device Sequence Number: 1
• Product Code: BTT
• UDI-Device Identifier: 09420012431066
• UDI-Public: (01)09420012431066(10)2100097323(11)161026
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Device Lot Number: 2100097323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2017
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/26/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2016
• 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