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

Model Number OPT316

Device Problem Device Handling Problem (3265)

Patient Problems Respiratory Distress (2045); Low Oxygen Saturation (2477)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Fisher & paykel healthcare are currently in the process of retrieving further information regarding this complaint.We will provide a follow up report upon the completion of our investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) representative that (b)(6) old critically ill patient was receiving nasal high flow heliox therapy using the opt316 optiflow junior nasal cannula.Prior to this event the child was anxious, difficult to console and agitated.The customer stated that the optiflow nasal cannula was "pulled/stretched from the distal end of the cannula near the colored connector and that it is assumed to have been done while the patient was agitated".It was further reported that the patient was coded blue and required chest compressions.Additional information from the attached medwatch reported showed that the patient was intubated for a couple of days and extubated and then returned home on (b)(6) 2019.

Manufacturer Narrative

(b)(4).Method: the complaint opt316 junior cannula was not returned to fisher & paykel healthcare for evaluation.Our investigation is thus based on the information and a photograph provided from the hospital replicating the reported failure as well as our knowledge of the product.Results: the additional information and photograph provided by the customer shows that one tube was stretched at the swivel grip end.The stretched tube was not detached from the swivel grip.Conclusion: we were unable to determine the cause of the reported failure.However the damage was most likely caused by an excessive pulling force being exerted on the tubing.According to the additional information provided by the hospital it was confirmed that the patient was inconsolable, agitated and flailing around when the event happened.All optiflow junior cannula 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 patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.- do not stretch or crush tube.

Event Description

A healthcare facility in utah reported via a fisher & paykel healthcare (f&p) representative that an 19 month old critically ill patient was receiving nasal high flow heliox therapy using the opt316 optiflow junior nasal cannula.Prior to this event the child was anxious, difficult to console and agitated.The customer stated that the optiflow nasal cannula was "pulled/stretched from the distal end of the cannula near the colored connector and that it is assumed to have been done while the patient was agitated".It was further reported that the patient was coded blue and required chest compressions.Additional information from the attached medwatch reported showed that the patient was intubated for a couple of days, extubated and then returned home on (b)(6) 2019.

• 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: 8490036
• MDR Text Key: 141170469
• Report Number: 9611451-2019-00303
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 03/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: OPT316
• Device Catalogue Number: OPT316
• Device Lot Number: 2100406673
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/09/2019
• Initial Date FDA Received: 04/07/2019
• Supplement Dates Manufacturer Received: 04/15/2019
• Supplement Dates FDA Received: 05/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 19 MO
• Patient Weight: 13