MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT NASAL INTERFACE; CAT

Model Number OPT844

Device Problem Device Handling Problem (3265)

Patient Problem Death (1802)

Event Date 07/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The opt844 interface is used to deliver humidified oxygen to patients.The opt844 consists of a lightweight delivery tube which is connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and also includes a lanyard which is placed around the patient's neck or attached to the patient's clothing or bedding to remove the load of the breathing circuit from the patient's nares.Method: the complaint opt844 nasal cannula was returned to fisher & paykel healthcare (b)(4) for evaluation and was visually inspected.Result: visual inspection of the device revealed that the tubing of the opt844 was found to be pulled out of the connector.The tubing was found stretched about 70 mm away from the connector end.Conclusion: the customer informed us that the cannula was in use for about six days before the incident occurred, which suggests the cannula was set up and performing as intended when it was put on the patient and that it operated correctly for that period.It was also reported to us by the hospital that the nurse in charge of the patient said that the "patient pulled the cannula" at the time of the incident.This would have created a leak in the system causing the patient to desaturate.Soon after the incident happened and the new cannula was put in place, the patient's spo2 was increased again.Previous investigations into this type of damage have shown that an excessive amount of force is required to damage the tubing in this manner.The complaint cannula would not have passed testing on the production line in its damaged condition.The death occured a day after this incident and we were informed that the patient was suffering from diffuse interstitial fibrosing pneumonia and chronic obstructive pulmonary disease, which may have contributed to the death.According to the doctor's opinion, there was no causal relationship between opt844 incident and the death which occured a day later, as the patient was stable soon after the cannula was exchanged.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discoloration and stretching or deformation.Any product that fails the visual inspection is disposed of.The user instructions which accompany the opt844 cannula show in pictorial format the correct placement and fitting of the cannula and also warn: 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 crush or stretch tube.

Event Description

A hospital in (b)(6) reported via a distributor that the tubing of an opt844 nasal cannula came apart from the connector during use on (b)(6) 2018.As a result, the patient's spo2 level was decreased to 70% level.A new opt844 cannula was put in place and the spo2 of the patient increased soon after.We were also informed that the patient had the primary disease of diffuse interstitial fibrosing pneumonia and chronic obstructive pulmonary disease.On (b)(6) 2018, the patient died.According to the doctor's opinion, there was no causal relationship between opt844 incident and the death which occured a day later, as the patient was stable soon after the cannula was exchanged.

• Brand Name: ADULT NASAL 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 7770091
• MDR Text Key: 116718688
• Report Number: 9611451-2018-00674
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/10/2018

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: OPT844
• Device Catalogue Number: OPT844
• Device Lot Number: 2100284736
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2018
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 08/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2017
• 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 Outcome(s): Death
• Patient Age: 77 YR