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

Model Number 201-30500

Device Problems Loss of Power (1475); Device Inoperable (1663); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 04/11/2017

Event Type  Injury  

Event Description

Patient who was on extracorporeal membrane oxygenation (ecmo) support via centrimag generation 2, was being transported via bed from o.R.Back to icu.Reportedly, during transport, the top monitor of the ecmo machine started to flicker, and the bottom monitor continued to show revolutions per minute (rpms) and flow.Transport continued during which time the ecmo pump completely stopped and lost power.Reportedly, the ecmo circuit was clamped and unsuccessful attempts were then made to transfer the driver cable to the back-up driver from the centrimag pump.Reportedly, because the cable would not go in, the head was changed to the back-up driver head after which flow was reestablished.All devices were plugged into the wall.The patient reportedly required resuscitation during this incident.Patient was then placed on a centrimag first generation pump without event, and transported back to o.R.To evaluate heart function.Reportedly, patient's hemodynamics returned to baseline after event.

• Brand Name: CENTRIMAG
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6085 stoneridge dr.; pleasanton CA 94588
• MDR Report Key: 6568819
• MDR Text Key: 75259538
• Report Number: 6568819
• 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: 04/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Model Number: 201-30500
• Other Device ID Number: GENERATION 2
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2017
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/21/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 54 YR