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

Model Number CENTRIMAG

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 09/11/2019

Event Type  malfunction  

Event Description

Centrimag presenting with alarm of "battery failure".Rn and perfusionist changed pump and console.Locking screw not properly threaded on back up pump, so a second back up needed to be brought in and use.Pump clamped twice to complete this.Patient tolerated well.Mom and patient informed of issue.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 9244366
• MDR Text Key: 163938056
• Report Number: 9244366
• 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: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: CENTRIMAG
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/12/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/28/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 7300 DA