MAUDE Adverse Event Report: LIVANOVA USA, INC. CP5; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number SORMED/CP5

Device Problems Device Inoperable (1663); Operating System Becomes Nonfunctional (2996)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 10/27/2017

Event Type  malfunction  

Event Description

Intraoperatively, cardiopulmonary bypass machine (cpb) main touch screen froze and the pump stopped working causing patient's blood pressure to drop.Unable to monitor flow/pressure or rpms.Cardiac output supported using cpb hand crank and internal cardiac massage while rebooting machine several times.No problem identified with cannula sites or tubing.Screen remained frozen but able to monitor flow and rpms.Switched to veno-arterial extracorporeal membrane oxygenation (va ecmo) support.Surgery was completed and patient transferred icu.

• Brand Name: CP5
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA USA, INC.; scott light; 14401 west 65th way; arvada CO 80004
• MDR Report Key: 7112241
• MDR Text Key: 94693872
• Report Number: 7112241
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SORMED/CP5
• Other Device ID Number: 403106637
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NO; OTHER