MAUDE Adverse Event Report: EUROSETS S.R.L. AMG PMP INFANT OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Catalog Number US5088

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 06/28/2023

Event Type  malfunction  

Event Description

Patient became hypotensive.It was then noticed that the pediatric oxygenator had blood coming out of gas exhaust port and pooling on ground.No air was seen in arterial line and no blood was seen in heater cooler line.Cardiac md attending notified.Emergent circuit change out completed by 2 ecmo specialist without issue.It was noted to be a fiber leak from perfusion services director.

• Brand Name: AMG PMP INFANT OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): EUROSETS S.R.L.; 3234 ibis street; san diego CA 92103
• MDR Report Key: 17469458
• MDR Text Key: 320502497
• Report Number: 17469458
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: US5088
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/30/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Patient Weight: 2 KG