MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SORIN; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Patient Problems Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477)

Event Date 08/14/2023

Event Type  Injury  

Event Description

Cardiopulmonary bypass machine malfunctioned during procedure - described as stopped working to the extent that there was no circulation until a new bypass machine was hooked up and started (approximately 8-10 minutes) requiring massive interventions like code level medications, blood products and cardiac massage.Staff from perfusion identified the tubing as a possible cause of malfunction.Manufacturer response for cardiopulmonary bypass machine, (brand not provided) (per site reporter).Not known at this time.

• Brand Name: SORIN
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 17911754
• MDR Text Key: 325379548
• Report Number: 17911754
• Device Sequence Number: 1
• Product Code: DTQ
• 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: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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: 08/15/2023
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 25915 DA
• Patient Sex: Male
• Patient Weight: 113 KG
• Patient Race: White