MAUDE Adverse Event Report: FISHER & PAYKEL HEALTHCARE LTD END EXPIRATORY FILTER; CAH

Model Number RT020

Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).We are currently in the process of obtaining further information from the customer to determine if the complaint rt020 expiratory filter caused or contributed to the reported event.We will provide a follow up report upon completion of the investigation.

Event Description

A healthcare facility in (b)(6) reported via a fisher & paykel healthcare (f&p) field representative that a rt020 end expiratory filter issue occurred during use.The patient, who was in the intensive treatment unit with a traumatic brain injury, had their intra-cranial pressure shoot up.

Manufacturer Narrative

(b)(4).The rt020 end expiratory filter (rt020 filter) is a single use product designed as bacterial/viral filter to prevent contamination of the ventilator by microorganisms present in the ventilatory gases of patients undergoing treatment.The complaint rt020 filter has not been received by fisher & paykel healthcare (f&p) for evaluation.Our investigation is thus based on the information provided by the customer, our knowledge of the product and previous investigations into similar complaints.This customer had experienced an occluded rt020 filter during use with nebulized drugs.The occlusion of the filter was most likely due to the rt020 filter being saturated with the saline solution while nebulized drugs were being administered to the patient.Rt020 end expiratory filters are visually inspected and pressure tested for leaks before leaving the production line, and those that fail are rejected.The complaint rt020 filter would have met the required specifications at the time of production.Our user instructions which accompany the rt020 filter state: change every 24 hours or sooner if noticeable deterioration occurs, following standard hospital procedure.When nebulized drugs are used resistance to flow should be monitored and the product replaced, following standard hospital procedure.

Event Description

A healthcare facility in the uk reported via a fisher & paykel healthcare (f&p) field representative that a rt020 end expiratory filter issue occurred during use.The patient, who was in the intensive treatment unit with a traumatic brain injury, had their intra-cranial pressure shoot up.F&p sought further information from the hospital regarding this incident.However, the healthcare facility was unable to provide further clarity.No further patient consequence was reported.

• Brand Name: END EXPIRATORY FILTER
• Type of Device: CAH
• 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: faranak gomarooni ; 173 technology drive; suite 100; irvine, CA 92618 ; 9194534000
• MDR Report Key: 9101792
• MDR Text Key: 176451912
• Report Number: 9611451-2019-00910
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K002839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RT020
• Device Catalogue Number: RT020
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/23/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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