MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH PRIM CONS 1ST GEN, STANDALONE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30100

Device Problems Overheating of Device (1437); Insufficient Information (3190); Unexpected Shutdown (4019)

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

Event Date 05/01/2023

Event Type  malfunction  

Event Description

Related manufacturer report numbers: 3003306248-2023-01929.It was reported that the specialist received a call from the hospital at 10:30pm, which informed that the centrimag console had a system error and smelled of burning.The doctor then reported that the motor had stopped working for over 10 minutes and they were afraid this would cause thrombosis.The pump was not exchanged to the backup pump.Instead, when the specialist arrived at 11:00 pm, the patient was switched from the centrimag to extracorporeal membrane oxygenation (ecmo) support.

Manufacturer Narrative

No additional information has been provided and no additional follow-up attempts will be performed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a system error was not confirmed; however, the reported event of a burning smell was confirmed.The centrimag 1st generation primary console (serial #: (b)(6)) to the service depot.The console was plugged into power and turned on.The console was unable to boot up and a burning smell was noticed, confirming the reported event.The console was opened for an internal inspection.Electrically damaged components were observed on the lmcep printed circuit board (pcb).This console is a 1st generation console and is unable to be repaired due to being obsolete and parts for repair no longer being available.The console was removed from service.Additional provided information communicated on 09may2023 stated that the hcp ruled out thrombus and rechecked the pump and did not find any thrombus.The patient is stable.It is planned to use ecmo for rv support.The root cause for the reported event was conclusively determined to be due to damage to the lmcep pcb within the console; however, a further root cause was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 1st generation primary console (serial #: 001201) and the console was found to pass all manufacturing and quality assurance specifications.The centrimag primary console section 3 entitled ¿about the primary console¿ warns ¿one back-up console and motor are required in the immediate vicinity of each patient whenever the centrimag or pedivas 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¿.The centrimag primary console table 12 entitled ¿primary console alarms & alerts¿ details how to interpret and troubleshoot all system alarms including system fault alarms: ¿the blood pump will stop.An audible alarm will sound which cannot be muted.Clamp the return tubing and switch to the backup system according to the procedure described in section 8.1.Resume support.Record the alarm message and contact your thoratec representative¿.The centrimag primary console section 8.1 entitled ¿switching to back-up hardware¿ provides instruction on how to properly switch to backup equipment.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: PRIM CONS 1ST GEN, STANDALONE
• 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: 16948745
• MDR Text Key: 315936391
• Report Number: 3003306248-2023-01928
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 7640135140702
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2011
• 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
• Patient Age: 54 YR
• Patient Sex: Male
• Patient Weight: 80 KG