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

Model Number RT266

Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

A hospital in (b)(6) reported to a fisher & paykel healthcare field representative that an rt266 infant dual-heated evaqua2 breathing circuit failed the routine-check before use.The customer confirmed an air leak from the dryline tube of the rt266 circuit.

Manufacturer Narrative

(b)(4).Method: the complaint rt266 infant dual heated evaqua2 breathing circuit was returned to fisher & paykel healthcare in new zealand for evaluation.The circuit was visually inspected and subsequently submerged in a water bath to determine the location of the leak.Results: visual inspection of the returned dryline revealed that the distal corrugation on the tube appeared to have been compressed and pinched.There was a pin-sized hole next to the compressed part of the corrugation.Stress marks were present on the chamber end tube collar.Visual inspection revealed that the circuit was damaged near the distal end connector and a pin-sized hole was noted on the tube.Stress marks were also noted on the chamber end connector on the returned dryline tube.The water bath test showed bubbles forming from the pin-sized hole.A lot check revealed one other complaint of this nature for lot 141212.Conclusion: we are unable to accurately determine what may have caused the damage observed on the returned dryline tube.The dryline tube is a supplied part and the supplier has informed us that the dryline tubes are visually inspected for pin holes during packaging.Additionally, fph perform a sample pressure and leak test of the dryline tubes received prior to assembling the circuits.The user instructions that accompany the rt266 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 correctly tested the circuit prior to patient use, which is in line with our user instructions.

• Brand Name: INFANT 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: 4770527
• MDR Text Key: 5776950
• Report Number: 9611451-2015-00239
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K103767
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2015

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: RT266
• Device Catalogue Number: RT266
• Device Lot Number: 141212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2015
• Initial Date Manufacturer Received: 04/15/2015
• Initial Date FDA Received: 05/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/12/2014
• 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
• Treatment: PB840 VENTILATOR