MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problem Pumping Stopped (1503)

Patient Problem Death (1802)

Event Date 11/05/2019

Event Type  Injury  

Manufacturer Narrative

Patient age was not provided.Serial number was not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag motor stopped.According to additional information provided, the patient expired on (b)(6) 2019 due to another cause.The device will be sent for repair.No further detail was provided.

Event Description

Patient was on lvad cmag 1st generation console.Transported to ct scan and discovered brain ischemia.Transported back to intensive care unit (icu) flow on 1st gen console; hemodynamics remained stable.Customer reported he felt motor and felt it vibrating as if it was flowing, but the motor felt a little warmer.They switched to another 1st gen console and that didn¿t resolve the problem.They switched to a second motor and that resolved the problem.Later they placed the motor that had the problem with on a demo loop and the problem reoccurred.The next day, they spoke with the family about the brain ischemia and discontinued support.Patient expired (b)(6) 2019 but not due to centimag motor failure.Educated the perfusionist on to switch console and motor, and figured the problem out later.Not to plug the system into a power strip, plug directly into outlet.Not to share outlet with other large medical devices.No further information was provided.

Event Description

Additional information was received on (b)(6) 2020.The console failed during a routine pm.It would not read the flow rate accurately.It was boxed and ready to be returned for evaluation regarding the flow rate issue.

Manufacturer Narrative

Section b5, d4: additional information.

Event Description

Patient death reported under mfr # 2916596-2019-05309.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag 1st generation primary console (serial #: (b)(6) ) was evaluated for the reported event of the centrimag motor stopping.The console was not returned for analysis; however, the associated centrimag motor (serial #: (b)(6) ) was returned for analysis and the reported event was confirmed and motor cable damage was found.Centrimag motor instructions for use instructs to always have a back-up centrimag motor available.Centrimag blood pump instructions for use states "always have a spare centrimag blood pump, back-up console and equipment available for change out." centrimag primary console operating manual warns "one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag blood pump is used.The back-up console must be connected to the back-up motor, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the primary console or primary motor experience a malfunction." no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9369731
• MDR Text Key: 167812104
• Report Number: 2916596-2019-05582
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 7640135140702
• UDI-Public: (01)7640135140702(21)
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US.
• Patient Outcome(s): Death
• Patient Age: 69 YR
• Patient Weight: 106