MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Electrical /Electronic Property Problem (1198)

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

Event Date 03/05/2021

Event Type  malfunction  

Event Description

It was reported that the centrimag generation 2 had reported a battery module failure message.The battery maintenance was performed on the unit with no issues.The centrimag console was switched out without incident.The initiation of centrimag support for the patient was (b)(6) 2021.The patient was still in the hospital.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a battery module failure was confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded for review with events spanning approximately 4 days ((b)(6) 2021 per time stamp).Events occurring on (b)(6) 2021 took place during lab testing at abbott.Following power up, on (b)(6) 2021 at 09:49:49 a ¿battery module fail: b1¿ alarm activated.The alarm was muted at 09:55:37.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned for analysis and the reported event of a battery module failure message was confirmed when the console was powered on.Battery maintenance was then performed successfully, and the console was then run on a test loop for several days and no alarms were present.The battery was replaced with a new battery and the console was run again on a test loop for several days and operated as intended.The console was functionally tested and performed as intended.The console was returned to the customer.The replaced battery was forwarded to product performance engineering (ppe) for further analysis.The returned battery was connected to a test centrimag system and no alarms were active upon powering on the console.A successful battery maintenance was performed.No alarms were active, and the reported event could not be reproduced again.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag 2nd generation primary console (serial #: (b)(6) ) and the console was found to pass all manufacturing and qa specifications.The device history records were reviewed for the centrimag battery (serial #: (b)(6)) and the battery was found to pass all manufacturing and qa specifications.The battery has an expiration date of 28feb2022.The 2nd generation centrimag system operating manual section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, 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 main console, motor or flow probe experience a malfunction." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." the 2nd generation centrimag system operating manual section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events, including b1 alarms.Table 13 entitled ¿console alarms & alerts¿ states ¿switch to the backup console, motor and flow probe according to the procedure described in section 10.1.Resume support.Record the alarm message and contact your abbott medical representative¿.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND 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: 11588294
• MDR Text Key: 243920979
• Report Number: 2916596-2021-01443
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/15/2021

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: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2021
• Initial Date FDA Received: 03/30/2021
• Supplement Dates Manufacturer Received: 06/10/2021
• Supplement Dates FDA Received: 06/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 107