MAUDE Adverse Event Report: THORATEC CORPORATION CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; Control, pump speed, cardiopulmonary bypass

Model Number 102954

Device Problem Electrical Power Problem (2925)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.Section e1: reporter address line 1: (b)(6).Section e1: reporter postal office or zip code: (b)(6).

Event Description

It was reported that the motor stopped and got very hot.

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was additionally reported that the equipment was in use on a bi-ventricular assist device (vad) patient and ran for a couple of weeks with no issue.There was suddenly a drop in flow approximately 4 liters per minute to zero flow with zero revolutions, and then immediately went back up to 4 liters per minute.A couple second later the pump flow dropped to zero flow again with zero revolutions and did not recover.The extracorporeal membrane oxygenation (ecmo) coordinator performed an emergency motor change, which involved changing the console and flow probe.The faulty group of equipment was removed.It was noted that the motor was very hot to touch and took a long time to cool down.The patient received some downtime without ecmo flow but had enough heart reserve to cope while the motor was changed out.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: Control, pump speed, cardiopulmonary bypass
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 19148018
• MDR Text Key: 341138379
• Report Number: 3003306248-2024-00475
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2024
• 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: 04/12/2024
• Was Device Evaluated by Manufacturer?: No
• 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