MAUDE Adverse Event Report: PALL CORPORATION ULTIPOR 25 ANESTHESIA BREATHING CIRCUIT SYSTEM FILTER; FILTER, BACTERIAL, BREATHING-CIRCUIT

Model Number BB25AB

Patient Problem Diminished Pulse Pressure (2606)

Event Date 11/28/2023

Event Type  Injury  

Event Description

Patient had hepa/hme filter when in use for a travel with a travel ventilator.Hepa/hme inadvertently left on for 14 hours after return from travel and connected to ventilator with heated wire circuit.Filter accumulated moisture and clogged.Unstable patient decompensated and lost pulse briefly -code x 20sec-1min before returning pulse.

• Brand Name: ULTIPOR 25 ANESTHESIA BREATHING CIRCUIT SYSTEM FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-CIRCUIT
• Manufacturer (Section D): PALL CORPORATION; 25 harbor park dr; port washington NY 11050
• MDR Report Key: 18300188
• MDR Text Key: 330159319
• Report Number: 18300188
• Device Sequence Number: 1
• Product Code: CAH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/07/2023,12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: BB25AB
• Device Catalogue Number: BB25AB
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 22265 DA
• Patient Sex: Male
• Patient Weight: 80 KG
• Patient Race: White