MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 MAST ROLLER PUMP 150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	10-88-00
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	Brain Injury (2219)
Date of Event	08/18/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Livanova deutschland has received a report that the main arterial pump failed while weaning off bypass.The patient is still alive and suffer brain injury.The s5 is seized.

• Brand Name: SRD S5 MAST ROLLER PUMP 150
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• MDR Report Key: 17744545
• Report Number: 1718850-2023-01013
• Device Sequence Number: 4185065
• Product Code: DTQ
• UDI-Device Identifier: 04033817900474
• UDI-Public: (01)04033817900474(11)220209
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2023
• Report Date (Section F): 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 10-88-00
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/18/2023
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown