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

Model Number RT380

Device Problem Ventilation Problem in Device Environment (3027)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint device was recently returned to fisher & paykel healthcare in (b)(4) for evaluation.We will provide a follow up report upon completion of our investigation.

Event Description

A hospital in the (b)(4) reported that a patient on an rt380 adult dual-heated evaqua2 breathing circuit was unable to be ventilated.The hospital further reported that the patient was manually ventilated while they replaced the breathing circuit.No patient consequence was reported.

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 and pressure tested.Results: visual inspection of the returned circuit revealed that the filter material was discoloured and occluded.The pressure test revealed that the breathing circuit was within specification.A lot check could not be carried out as the lot information was not provided.Conclusion: based on the inspection carried out, the problem reported by the customer was most likely due to the use of an occluded filter in the set up.It is likely that the discolouration and occlusion of the filter material was the result of nebulized drugs.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.This suggests the damage noted on the filter was caused after the circuit was released for distribution.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." "change filter if noticeable deterioration occurs, following standard hospital procedure." "when nebulized drugs are used resistance to flow should be monitored and the filter replaced, following standard hospital procedure.".

Event Description

A hospital in the (b)(6) reported that a patient on an rt380 adult dual-heated evaqua2 breathing circuit was unable to be ventilated.The hospital further reported that the patient was manually ventilated while they replaced the breathing circuit.No patient consequence was reported.

• 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: 5083268
• MDR Text Key: 26252747
• Report Number: 9611451-2015-00412
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K122432
• 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: Followup
• Report Date: 08/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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