MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD OPTIFLOW JUNIOR INTERFACE; CAT

Model Number OPT016

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Leak/Splash (1354)

Patient Problem Low Oxygen Saturation (2477)

Event Date 04/20/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via their fisher & paykel healthcare representative that the port cap came off an optiflow junior adaptor, generating a leak and causing the patient to desaturate.No further patient consequence was reported.

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare did not receive the adapter for evaluation.Our investigation is thus based on our knowledge of the product.The optiflow junior cannula adaptor has both a nebuliser port and a luer lock for gas sampling.The customer had reported that the luer port cap had come off during patient use.The hospital informed us that they did not know whether it was the patient who removed the port cap or if it occurred by accident.No further information was provided regarding the reported patient desaturation.The port cap is designed to be removable in order to connect a gas line.During production a line operator fits the luer cap over the luer port of the adapter housing and ensures that the cap is firmly pressed on to the adaptor housing.When properly fitted, the port cap forms a tight fit with the luer port and will not loosen easily.This is the only complaint of this nature that we have received.All opt016 adaptors are transport tested before being released for distribution and one of the pass criteria is that there should be no dislodged caps.Any that fail the tests are rejected.The user instructions illustrate in pictorial format the correct set-up and proper use of the optiflow junior nasal cannula.They also state the following: check that all connections, caps and/or plugs are tight before use.Appropriate patient monitoring must be used at all times.

• Brand Name: OPTIFLOW JUNIOR INTERFACE
• Type of Device: CAT
• 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: 4786795
• MDR Text Key: 15303998
• Report Number: 9611451-2015-00247
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT016
• Device Catalogue Number: OPT016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 1 YR
• Patient Weight: 10