MAUDE Adverse Event Report: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT; BZE

Model Number RT380

Device Problems Loose or Intermittent Connection (1371); Device Handling Problem (3265)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The complaint rt380 adult dual heated evaqua2 breathing circuit was received at fisher & paykel healthcare (f&p) (b)(4) for evaluation to determine if f&p's product caused or contributed to the reported event.Evaluation is anticipated but not yet begun.We will provide a follow up report upon completion of our investigation.

Event Description

A distributor in (b)(6) reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the connector of a rt380 adult dual heated evaqua2 breathing circuit became loose during use.There was no reported patient consequence.

Manufacturer Narrative

(b)(4).Method: the inspiratory circuit of the complaint rt380 evaqua2 breathing circuit was returned to fisher & paykel healthcare new zealand and was visually inspected.Result: the visual inspection revealed that the inspiratory limb was returned with the elbow and patient end connector loose.Conclusion: we were unable to determine conclusively the cause of the reported event.However, it is possible that the circuit was cleaned and reused which could lead to the reported event.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.If any faults are detected the whole batch is placed on hold for investigation.This suggests that the damage occurred after the product was released for distribution, during transportation or storage.The user instructions that accompany the rt380 breathing circuit state the following: check all connections are tight before use.Set appropriate ventilator alarms.Do not soak, wash, sterilize, or reuse this product.Avoid contact with chemicals, cleaning agents, or hand sanitizers.Reuse may result in transmission of infectious substances, interruption to treatment, serious harm or death.

Event Description

A distributor in japan reported on behalf of a healthcare facility via a fisher & paykel healthcare (f&p) field representative that the connector of a rt380 adult dual heated evaqua2 breathing circuit became loose during use.There was no reported patient consequence.

• Brand Name: ADULT DUAL HEATED EVAQUA2 BREATHING CIRCUIT
• Type of Device: BZE
• MDR Report Key: 9784578
• MDR Text Key: 187413792
• Report Number: 9611451-2020-00240
• Device Sequence Number: 1
• Product Code: BZE
• Combination Product (y/n): N
• PMA/PMN Number: K122432
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• 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: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2020
• Date Manufacturer Received: 03/16/2020
• 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