MAUDE Adverse Event Report: PALL / GLOBAL LIFE SCIENCES SOLUTIONS USA LLC. PALL ULTIPOR 100 HME; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number ULTIPOR 100

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Diminished Pulse Pressure (2606); Respiratory Arrest (4461)

Event Date 01/27/2024

Event Type  Death  

Event Description

Rt: pt was on a neb treatment on the vent / had just completed the treatment, when she brady' d down to puleslessness.Rt responded to find the patient difficult to bag.Removed circuit with hme and bagged to trach with no issues.Hme did not appear to be gunked up but would not allow air to flow through.Acls performed but patient expired.

• Brand Name: PALL ULTIPOR 100 HME
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): PALL / GLOBAL LIFE SCIENCES SOLUTIONS USA LLC.
• MDR Report Key: 18659915
• MDR Text Key: 334814411
• Report Number: MW5151114
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ULTIPOR 100
• Device Lot Number: 320102
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic