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 Insufficient Information (4580)

Event Date 10/20/2022

Event Type  malfunction  

Manufacturer Narrative

Voluntary medwatch number mw5113026 was received 04-nov-2022.Manufacturer's investigation conclusion: the reported event of a centrimag not being able to function properly was unable to be confirmed.The centrimag 1st generation primary console was not returned for analysis and no log files were submitted for review.Multiple good faith efforts were sent asking for the serial number of the centrimag console, if there was any patient impact related to the console exchange due to centrimag failure, if there were any events leading up to the reported failure, and if any products would be returned for evaluation.To date, no response has been received.A root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were unable to be reviewed for the centrimag 1st generation primary console due to no serial number being provided.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.

Event Description

It was reported that a patient that was on veno-arterio-venous (vav) extracorporeal membrane oxygenation (ecmo) had a centrimag pump failure.The centrimag console was switched to the backup and the patient remained stable throughout the event.

Manufacturer Narrative

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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15868548
• MDR Text Key: 304372775
• Report Number: 3003306248-2022-14513
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/04/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 11/29/2022
• Supplement Dates FDA Received: 11/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1