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

Model Number RT380

Device Problems Device Damaged Prior to Use (2284); Failure of Device to Self-Test (2937)

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

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported that an rt380 adult dual-heated evaqua 2 breathing circuit failed the leak test prior to patient use.They further reported that the expiratory tube was split.

Manufacturer Narrative

(b)(4).Method: the complaint rt380 adult dual-heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in (b)(4) where it was visually inspected.Results: visual inspection revealed a cut in the expiratory tube approximately 71cm from the distal connector.The damage appeared to have been made with a sharp object.A lot check revealed no other complaints of this nature for lot 130530.Conclusion: the cut on the expiratory tube was most likely caused by a knife or boxcutter 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 hospital staff correctly checked the breathing circuit before patient use, which is in line with our user instructions.

• 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 ; 15365 barranca parkway; irvine, CA 92618-2216 ; 9494534000
• MDR Report Key: 3879141
• MDR Text Key: 4568385
• Report Number: 9611451-2014-00533
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• 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: 130530
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2014
• 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