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

Model Number OPT944

Device Problem Device Issue (2379)

Patient Problem Low Oxygen Saturation (2477)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint cannula is currently en route to fisher & paykel healthcare in order for us to determine if our product caused or contributed to the reported event.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in sweden reported that a patient was connected to an opt944 nasal cannula, mr850 humidifier and rt380 inspiratory limb, on high flow with 100% o2 and 60 litres of flow.Suddenly the patient's saturation dropped quickly and they lost consciousness.The doctor discovered that the opt944 nasal cannula was broken and no longer delivering flow to the patient.Once discovered the doctor reconnected the broken pieces, and saturation rose again from 20 - 88.Patient then woke up and was fully able to speak.The doctor confirmed that the patient was palliative and in a moribund state.

Manufacturer Narrative

(b)(4).The opt944 interface is used to deliver humidified oxygen to patients and consists of a lightweight delivery tube connected to a rigid plastic base and soft nasal prongs (nasal interface).The interface is held in place by a head strap and features a head strap clip which works in tandem with the tubing clip (attaches to the patient's clothing/bedding) to support the weight of the circuit and prevent the cannula being dislodged.Method: the complaint cannula was returned to fisher and paykel healthcare and was visually inspected.Results: visual inspection of the returned cannula revealed that the tubing was detached from the swivel connector.The swivel was found to be operational.Conclusion: the observed damage to the complaint cannula is likely the result of pulling on the cannula tubing with undue force.The customer was also not sure whether the clothing clip had been used.All optiflow interfaces are inspected during production for visual defects including cracks, tears, inclusions, discolouration and stretching or deformation.Any product that fails the visual inspection is disposed of.The setup instructions in the user instructions which accompany the opt944 nasal cannula include the following steps: ensure head strap clip is attached, to prevent cannula from being pulled out of the nares.Cannula can become unattached if not used with the head strap clip.Attach tubing clip to clothing/bedding to prevent cannula from pulling off face.The user instructions also contain the following warnings/cautions: do not crush or stretch tube, to prevent loss of therapy.Failure to use the set-up described above can compromise performance and affect patient safety.Our optiflow production team has been notified of this failure.They have carried out an internal investigation of the manufacturing process and production staff have received additional training to ensure they are following the correct assembly procedure.

Event Description

A hospital in (b)(6) reported that a patient was connected to an opt944 nasal cannula, mr850 humidifier and rt380 inspiratory limb, on high flow with 100% o2 and 60 litres of flow.Suddenly the patient's saturation dropped quickly and they lost consciousness.The doctor confirmed that the patient was palliative and in a moribund state.The doctor discovered that the opt944 nasal cannula was broken and no longer delivering flow to the patient.Once discovered the doctor reconnected the broken pieces, and saturation rose again from 20 - 88.Patient then woke up and was fully able to speak.

• 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: jon stevens ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 6192114
• MDR Text Key: 62908560
• Report Number: 9611451-2016-00916
• Device Sequence Number: 1
• Product Code: CAT
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/12/2016

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: OPT944
• Device Catalogue Number: OPT944
• Device Lot Number: 2100070373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/12/2016
• Initial Date FDA Received: 12/20/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/06/2016
• 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
• Treatment: FISHER & PAYKEL MR850 HUMIDIFIER; FISHER & PAYKEL RT380 ADULT BREATHING CIRCUIT
• Patient Outcome(s): Required Intervention