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

Model Number OPT314

Device Problems Leak/Splash (1354); Device Handling Problem (3265); Material Split, Cut or Torn (4008)

Patient Problems Low Oxygen Saturation (2477); No Known Impact Or Consequence To Patient (2692)

Event Date 08/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint opt314 optiflow junior nasal cannulae are expected, but have not yet been returned to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare representative that there was a weakness in the junction between the tubing and cannula of two opt314 optiflow junior nasal cannulae which generated a tear and a leak.It was further reported that the cannulae were then removed from service and deliberately pulled very hard to reproduce the problem.No patient consequence was reported.

Event Description

A hospital in france reported via a fisher & paykel healthcare representative that there was a weakness in the junction between the tubing and cannula of two opt314 optiflow junior nasal cannulae which generated a tear and a leak.It was further reported that the cannulae were then removed from service and deliberately pulled very hard to reproduce the problem.Further information was recieved from the hospital that a desaturation occurred with the chid concerned.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the two complaint opt314 optiflow junior nasal cannulae were returned to fisher & paykel healthcare in new zealand for investigation where they were visually inspected.Further attempts to contact the hospital for further information with regards to the nature of the reported event, however no response was recieved.Results: visual inspection of the returned devices revealed that both cannulae were grossly damaged.Conclusion: we were unable to determine the cause of the reported failure as the complaint devices were returned badly damaged, however the healthcare facility confirmed that "the cannulas were removed and the service has deliberately pulled very hard to reproduce the problem, hence the condition of the cannulas." 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.

• 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
• MDR Report Key: 8026939
• MDR Text Key: 125922324
• Report Number: 9611451-2018-00930
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OPT314
• Device Catalogue Number: OPT314
• Device Lot Number: 2100456912
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Date Manufacturer Received: 10/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1