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

Model Number RT268

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/13/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4) the rt268 infant evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.The complaint breathing circuit is currently en route to fisher & paykel healthcare for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in (b)(6) reported that the swivel of an rt268 infant evaqua 2 breathing circuit came apart while in use on a patient.Nursing staff reported that the baby desaturated with bradycardia post suctioning; the baby required treatment with a neopuff resuscitator to increase heart rate and oxygen saturation.The baby was placed back on ventilator and desaturated again with associated bradycardia.Following neopuff treatment, good chest movement was seen and heart rate and saturation improved.As the nurse was about to place baby back on the ventilator it was noted that the connector at the patient end had separated into two parts.

Manufacturer Narrative

(b)(4).The rt268 infant evaqua2 breathing circuit is not sold in the usa but it is similar to a product sold in the usa.The 510(k) for that product is k103767.Method: the swivel from the complaint rt268 circuit was received and was visually inspected and mechanically tested.The rest of the complaint cicuit was not received.Results: visual inspection revealed no damage to the returned components (swivel elbow and swivel wye).The swivel was returned disassembled and once reassembled it formed a tight fit.A lot check revealed no other complaints for lot 150731.Conclusion: we are unable to determine what may have caused the problem reported by the customer.The infant swivel elbow and swivel wye is assembled using a machine to ensure a consistent tightness of connection.The swivel assembly is then 100% pressure and flow tested as part of the infant breathing circuit before leaving the production line.Any circuits that fail these tests are rejected.The user instructions that accompany the rt268 also state the following: check all connections are tight before use; perform a pressure and leak test on the breathing system and check for occlusions before connecting to a patient; set appropriate ventilator alarms.

Event Description

A hospital in (b)(6) reported that the swivel of an rt268 infant evaqua 2 breathing circuit came apart while in use on a patient.Nursing staff reported that the baby desaturated with bradycardia post suctioning; the baby required treatment with a neopuff resuscitator to increase heart rate and oxygen saturation.The baby was placed back on ventilator and desaturated again with associated bradycardia.Following neopuff treatment, good chest movement was seen and heart rate and saturation improved.As the nurse was about to place baby back on the ventilator it was noted that the connector at the patient end had separated into two parts.

• 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: 5305092
• MDR Text Key: 34262435
• Report Number: 9611451-2015-00536
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT268
• Device Catalogue Number: RT268
• Device Lot Number: 150731
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/31/2015
• 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