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

Model Number OPT318

Device Problem Device Handling Problem (3265)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/08/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: fisher & paykel healthcare did not receive a complaint cannula for this incident.A request was made to the hospital but they confirmed that they do not have the device.The hospital stated that three incidents involving three devices had occurred.Only two devices have been received and have been investigated against another of the three complaints.The three complaints and the additonal unused devices provided for our investigation were all from the same batch.Results: visual inspection of the two complaint cannulae received for one of the other complaints revealed that one or both of the flexitubes had become disconnected from the swivel grip.Visual inspection of the 30 unused cannulae provided by the hospital for this other complaint showed that there was no visible damage or defect with any of them.All 30 were pull tested and the joint strength was found to be within specification, with no detaching of the tubing from the swivel grip.Conclusion: we were unable to determine what had caused the observed damage.All optiflow junior cannulae are 100% leak and occlusion tested after final assembly and any cannula that fails is discarded.In addition, samples are taken hourly from each run and pull tested to check glue joint strength at the cannula/tube joint, as well as the swivel grip joint.If there are any failures the entire batch is put aside for further investigation.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: - ensure that all connections are secure during use.Check cannula is undamaged and that the flow path is maintained.- appropriate monitoring must be used at all times.- do not stretch or crush tube.

Event Description

A hospital in (b)(6) reported that a patient was on an opt318 optiflow junior nasal cannula when the cannula 'separated from the connector piece' and the patient desaturated.This complaint was not reported to fisher & paykel healthcare by the hospital.Fisher & paykel healthcare first became aware of this on (b)(6) 2016 and approached the hospital in order to confirm whether this was a separate incident from the two complaints previously reported.Confirmation was only received from the hospital on (b)(6) 2016 as to the number of incidents that had occurred.It was confirmed that there was no patient harm.

• 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 ; 173 technology drive; suite 100; irvine, CA 92618 ; 9494534000
• MDR Report Key: 5927932
• MDR Text Key: 53907739
• Report Number: 9611451-2016-00513
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/26/2016

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: OPT318
• Device Catalogue Number: OPT318
• Device Lot Number: 2100035782
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/27/2016
• Initial Date FDA Received: 09/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2016
• 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