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

Model Number 201-90411

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/27/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the centrimag console displayed "battery maintenance due" notification while connected to a patient.The console was exchanged with no issues while connected to the patient.The console did not pass the first battery maintenance check.It was planned to check the battery connections and re-run the battery maintenance check.

Manufacturer Narrative

E1: reporter email was unavailable.Manufacturer's investigation conclusion: the reported event of a battery maintenance due alarm was unable to be confirmed.The centrimag 2nd generation primary console (serial number: (b)(6)) was not returned for analysis.No log files were submitted for review.The root cause of the reported event was unable to be conclusively determined through this investigation.The device history records were reviewed for the centrimag 2nd generation primary console (serial number: (b)(6)) and the console was found to pass all manufacturing and 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 16 entitled ¿console alarms & alerts¿ states how to interpret and address all system alarms including battery maintenance due alarms.¿the console battery will not function.An audible alarm will sound.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.

Event Description

Additional information was received that the battery maintenance check was performed a second time and the battery failed again.Serial number of the failed battery and log files were not available.The failed battery was disposed of.

• 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: 17954420
• MDR Text Key: 326023687
• Report Number: 3003306248-2023-07163
• 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: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 01/12/2024

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: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: 201-90411
• Device Lot Number: 7612695
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/27/2023
• Initial Date FDA Received: 10/17/2023
• Supplement Dates Manufacturer Received: 01/10/2024
• Supplement Dates FDA Received: 01/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 4 YR
• Patient Sex: Male
• Patient Weight: 20 KG