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

Model Number 6596259

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Vibration (1674); Noise, Audible (3273)

Patient Problem No Information (3190)

Event Date 03/20/2019

Event Type  malfunction  

Event Description

Bedside rn called mcs rn into patient room with centrimag alarming.Bedside rn stating that pump head made high pitched whirling noise about 30 seconds before machine started alarming.Mcs rn noted both console's to be off while display monitor showing speed to be 3800 while flow was dashed out.Pump head making high pitched noise and increased vibration felt.After turning on the back up console, it was noted that the original console now back on and showing what the display is showing.Able to turn speed down and clamp in order to switch to the new pump/console.

• 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: 8543723
• MDR Text Key: 142883472
• Report Number: 8543723
• 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: 03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6596259
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/20/2019
• Event Location: Hospital
• Date Report to Manufacturer: 04/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 22265 DA