MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD INFANT OPTIFLOW? TUBING KIT; BTT

Model Number RT330

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/11/2014

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported via a fisher & paykel healthcare field representative that after a patient had been using an rt330 infant optiflow circuit for 36 hours, the humidifier alarmed and the chamber probe was found to have become detached from the setup.Upon discovering this staff reconnected the probe and continued to use the circuit for a further 14 hours without further incident.There was no patient consequence reported.

Manufacturer Narrative

(b)(4).The complaint rt330 was not returned to fisher & paykel healthcare for evaluation.The hospital continued to use it following the reported incident.The probe-probe port connection is a taper fit and when firmly placed in the probe ports the probes form a tight seal and require twisting and pulling to be removed.The hospital had confirmed that the system had been in place for 36 hours before the probe became detached.It is therefore likely that either the probe was not properly inserted and came loose or that it was accidentally pulled out of the probe port.The user instructions that accompany the rt330 show in pictorial format how to insert the probes into the inspiratory limb probe ports.They also include the following statements: check all connections, caps and/or plugs are tight before use.Patient monitoring is recommended.This is the only complaint of this nature that we have received for the rt330 breathing circuit.

• Brand Name: INFANT OPTIFLOW? TUBING KIT
• 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 ; 9494534000
• MDR Report Key: 3898767
• MDR Text Key: 19969207
• Report Number: 9611451-2014-00566
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Respiratory Therapist
• Type of Report: Initial
• Report Date: 06/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT330
• Device Catalogue Number: RT330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• 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: OPT318 OPTIFLOW JUNIOR CANNULA