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

Model Number 201-30300

Device Problem Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the centrimag primary console had a battery failure.The battery was replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag console (serial number: (b)(6) having an issue with its internal battery could not be confirmed.The unit was not returned to abbott for analysis, and provided information indicated that battery issue resolved and the equipment is now operating as intended.Log files were not submitted for review.The root cause of the reported event could not be conclusively determined via this analysis.The device history records were reviewed for the centrimag 2nd generation console (serial #: (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 8.4 entitled ¿battery operation¿ warns the user that once a low battery alert is displayed, ac power must be restored as quickly as possible.It is also noted that if the console is operating on batteries and a battery below minimum alarm is displayed, the pump could stop at any time without further warning.The user is instructed to operate the system at the lowest acceptable clinical flows when on battery power, so that the remaining battery time can be conserved.The 2nd generation centrimag system operating manual section 8.5 entitled ¿operation of the centrimagtm circulatory support system on internal console battery power¿ provides approximate console runtimes when operating on internal battery power.The 2nd generation centrimag system operating manual section 9.4 entitled ¿battery maintenance¿ indicates that the battery maintenance procedure needs to be performed every 6 months.The aim of the battery maintenance procedure is to fully charge the battery, then to discharge it against a load.During the discharge, the total energy stored in the battery is recorded and compared to system specifications.The 2nd generation centrimag system operating manual table 15 entitled ¿console maintenance schedule¿ indicates that the internal battery pack needs to be replaced every 2 years.The 2nd generation centrimag system operating manual table 16 entitled ¿console alarms & alerts¿ states how to interpret and address all system alarms including b1 battery module fail 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

It was additionally reported that the equipment was working without problems after battery replacement.

• 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: 17665877
• MDR Text Key: 322444849
• Report Number: 3003306248-2023-05064
• 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: 12/20/2023

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 Model Number: 201-30300
• Device Lot Number: 8885307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2023
• Initial Date FDA Received: 08/31/2023
• Supplement Dates Manufacturer Received: 12/19/2023
• Supplement Dates FDA Received: 12/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1