MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the two complaint rt380 adult evaqua2 breathing circuits were received at fph in (b)(4) for investigation.The returned devices were visually inspected.Our investigation is also based on information reported by the customer and past investigations into similar complaints.Results: visual inspection revealed a cut in the expiratory limb of both breathing circuits.The location of the cuts in the expiratory limbs were also found to match the cuts found in the top of the packaging bags also returned.The cuts appeared to have been cut by a sharp object such as a knife or box cutter.The healthcare facility reported that a box cutter is used to open boxes containing circuit kits.Conclusion: based on our experience of similar investigations and the information reported by the customer, we can conclude the damage most likely occurred when the circuit packaging box was opened.All rt380 breathing circuits are visually inspected and pressure tested for leaks before releasing for distribution.Any breathing circuit which fails any of these tests is discarded.In addition, tube weighing and bond strength testing are performed every 15 minutes.If any faults are detected the whole batch is placed on hold for investigation.The user instructions supplied with the rt380 breathing circuit state: perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient; set appropriate ventilator alarms.The healthcare facility also stated that they would be more careful in the future when using box cutters.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare representative that two rt380 evaqua2 adult breathing circuits were found to have cuts in the expiratory limb.The event was discovered during the leak test, before patient use.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• 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 ; 173 technology dr. suite 100; irvine, CA 92618 ; 8007923912
• MDR Report Key: 5747240
• MDR Text Key: 48097035
• Report Number: 9611451-2016-00279
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT380
• Device Catalogue Number: RT380
• Device Lot Number: 2100016955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2016
• Date Manufacturer Received: 05/25/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2016
• 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