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

Model Number RT330

Device Problems Component Missing (2306); Device Issue (2379)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Our investigation is currently in progress.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) representative that the oxygen port cap on the pressure relief valve included in the rt330 optiflow junior tubing kit was missing.The hospital reported that this was noticed after 10 minutes of use as the patient's "sats" dropped.The hospital changed the rt330 optiflow junior tubing kit with a new one and continued to provide therapy.No patient consequence was reported.

Manufacturer Narrative

(b)(4).Method: the complaint device was not returned to fisher & paykel healthcare in (b)(4) for evaluation.Therefore our investigation is based on the information provided by the customer and our knowledge of the product.Results: it was reported that the oxygen port cap was missing from the pressure relief valve.A lot check could not be carried out as the lot information was not provided by the customer.Conclusion: without the return of the complaint device we are unable to determine what may have caused the problem reported by the customer.All rt330 optiflow junior tubing kits including the pressure relief valve are pressure and leak tested prior to being released for distribution.The pressure and leak test is followed by a visual inspection of the devices.Any circuits or pressure relief valves that fail are rejected.The user instructions that accompany the rt330 optiflow junior tubing kit state the following: "check all connections, caps and/or plugs are tight before use"; "patient monitoring is recommended"; "discard product if the pressure relief valve is damaged or damage is suspected"; "discard product if the blue cover on the pressure relief valve has been removed or is missing".Since the reported incident a fisher & paykel healthcare representative has visited the customer.

Event Description

A hospital in the (b)(6) reported to a fisher & paykel healthcare (fph) representative that the oxygen port cap on the pressure relief valve included in the rt330 optiflow junior tubing kit was missing.The hospital reported that this was noticed after 10 minutes of use as the patient's "sats" dropped.The hospital changed the rt330 optiflow junior tubing kit with a new one and continued to provide therapy.No patient consequence was reported.

• Brand Name: OPTIFLOW JUNIOR 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: 5249420
• MDR Text Key: 32248753
• Report Number: 9611451-2015-00499
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K020332
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/26/2015
• Initial Date FDA Received: 11/25/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• 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