MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT BREATHING CIRCUIT; BTT

Model Number RT202

Device Problem Disconnection (1171)

Patient Problem Low Oxygen Saturation (2477)

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complaint rt202 breathing circuit and opt944 nasal cannula were not returned to fisher & paykel healthcare (fph) in (b)(4) for evaluation as they had been discarded by the hospital.The following information was provided by the hospital: the incident happened several weeks earlier but the hospital did not report it to fph at that time.The hospital has confirmed that there was a disconnection of the rt202 circuit from the opt944 cannula and that there was no breakage or malfunction of either of the devices themselves.Setup was with a blender and humidifier but the actual devices used were not specified.The patient was not being monitored: no pulse oximetry or other forms of monitoring.This incident has prompted the hospital to review monitoring of palliative care patients.The time and date of the incident was not provided by the hospital.Based on the description of events provided by the hospital, we can conclude that the rt202 circuit and the opt944 patient interface became disconnected at some stage, leading to a deterioration in the patient's condition.As it was confirmed that there was no defect or malfunction of either the rt202 circuit or the opt944 cannula, it is not clear how the disconnection occurred.The hospital has confirmed that the patient was not being monitored when the incident occurred.When properly connected the circuit and interface form a tight fit and cannot disconnect spontaneously.The connection is a standard 22mm medical taper fit and conforms to iso 5356-1: anaesthetic and respiratory equipment -- conical connectors.All breathing circuits are pressure tested for leaks during production and those that fail are rejected.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 user instructions that accompany the rt202 adult breathing circuit contain the following: check all connections are tight before use.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: appropriate patient monitoring must be used at all times.Failure to monitor the patient may result in loss of therapy, serious injury or death.Failure to use the set-up described above can compromise performance and affect patient safety.

Event Description

A hospital in (b)(6) reported via a fisher and paykel healthcare representative that an rt202 adult inspiratory heated breathing circuit became disconnected at the connection between the circuit and the patient interface.The patient was m1 palliative and was unattended for half an hour; when found, the patient was desaturated and their condition had deteriorated.

• Brand Name: ADULT BREATHING CIRCUIT
• Type of Device: BTT
• 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9194534000
• MDR Report Key: 5969057
• MDR Text Key: 55315726
• Report Number: 9611451-2016-00584
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K983112
• 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
• Report Date: 08/25/2016

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: RT202
• Device Catalogue Number: RT202
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/25/2016
• Initial Date FDA Received: 09/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 OPT944 NASAL CANNULA
• Patient Outcome(s): Required Intervention