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

Model Number 201-30300

Device Problems Failure to Power Up (1476); Insufficient Information (3190); Complete Loss of Power (4015)

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

Event Date 06/29/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console did not receive power when plugged into the hospital's power.The device did operate with the backup battery, however, during an engineer review of the device it appeared there was an issue with the battery.The device was not in use with a patient at the time of the event.

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the console not operating on ac power and the reported event of the battery not passing battery maintenance were not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) was not returned for analysis.Additional provided information communicated on 08jul2023 stated that the cause of lack of energy was not identified because when the engineer attended, he did not show an issue or any related alarm.At the moment, it is working well in that it did not present this specific problem again.Additional provided information communicated on 23aug2023 stated that there were no alarms related to the battery issue.The battery did not pass the preventative maintenance twice and needed to be changed, resolving the issue.There are no log files available for review.The battery was exchanged but it will not be returned for analysis; it was scrapped.The root cause for the reported events were 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 quality assurance (qa) specifications.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 table 15 entitled ¿console maintenance schedule¿ states to replace the internal battery every 2 years and perform battery maintenance every 6 months.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information reported that the battery was exchanged, and the issue resolved.

• 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
• 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: 17326245
• MDR Text Key: 319317435
• Report Number: 3003306248-2023-01962
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K131179
• 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: 09/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Lot Number: 8885309
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2011
• 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