MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Pt has a centrimag (rvad) after having a suction event an alarm popped up that said "battery maintenance required-b4" i checked to make sure that everything was properly plugged in and connected and it was.Perfusion paged and to bedside immediately.They also checked connections, everything properly plugged in.Biomed paged.Centrimag consoles exchanged.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge dr; pleasanton CA 94588
• MDR Report Key: 8342898
• MDR Text Key: 136272253
• Report Number: 8342898
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA