MAUDE Adverse Event Report: TRI-ANIM HEALTH SERVICES, INC. BACTERIAL AND VIRAL DEPTH FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number 301-435

Device Problems Complete Blockage (1094); Inadequate Filtration Process (2308)

Patient Problem Respiratory Distress (2045)

Event Date 06/08/2016

Event Type  malfunction  

Manufacturer Narrative

Event Description

This report is being filed at the request of the patient's wife who believes the placement of a bacterial/viral filter proximal to the ventilator's exhalation valve contributed to her husband's respiratory distress.The filters are placed to protect the exhalation valve from the viscosity of inhaled colistin and are in accordance with the drug manufacturer's recommendation.The patient's wife's beliefs were based on her observations of what she describes as more than one similar occurrence.The hospital's investigation attributed the patient's respiratory distress to a large amount of retained secretions that were removed during bronchoscopy, causing the patient to recover from his respiratory distress.The patient's wife believes that the filters became clogged with the colistin causing increased resistance; however the ventilator readings failed to substantiate this theory.

• Brand Name: BACTERIAL AND VIRAL DEPTH FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): TRI-ANIM HEALTH SERVICES, INC.; 5000 tuttle crossing blvd; dublin OH 43016
• MDR Report Key: 5987169
• MDR Text Key: 55959133
• Report Number: 5987169
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 06/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2016
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 301-435
• Device Catalogue Number: 301-435
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/29/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 06/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 58