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

Model Number 201-90411

Device Problems Improper or Incorrect Procedure or Method (2017); Insufficient Information (3190); Unexpected Shutdown (4019)

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

Event Date 09/03/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related mfr # 2916596-2023-00576.It was reported that the pump cable was pulled out of the console instead of the monitor cable.The pump cord was plugged back in after which the centrimag console powered off and rebooted.After the reboot, flow returned to the original settings, but no flow was listed on the screen and an s3 alarm message was displayed.At this point, an emergency console change was performed at bedside.The patient tolerated the occurrence and was not harmed by the event.

Event Description

Related manufacturer report number: 3003306248-2023-00577.

Manufacturer Narrative

Section b5: related manufacturer report number corrected.Section h6: investigation findings: 4248 - usage problem identified.Manufacturer's investigation conclusion: the reported event indicated that the user disconnected the motor cable rather than the monitor cable.After the cable disconnection the reported event of the console turning off when the cable was re-connected, and when turned back on posted an s3 alarm and blank flow was not confirmed.The centrimag 2nd generation primary console (serial#: (b)(6) was not returned for analysis.Additional provided information communicated on 30jan2023 stated that attempts were made to retrieve information from the customer, including product return; however, the attempts were unsuccessful.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 and the console was found to pass all manufacturing and quality assurance specifications.The 2nd generation centrimag system operating manual, rev.M, 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, rev.M, 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, rev.M, section 12.1 ¿appendix i ¿ console alarms and alerts¿ table 16 details how to properly interpret and troubleshoot all system alarms including s3 alarms.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
• 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: 16258002
• MDR Text Key: 309148767
• Report Number: 3003306248-2023-00578
• 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,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/10/2023

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: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: 201-90411
• Device Lot Number: 7571523
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 01/27/2023
• Supplement Dates Manufacturer Received: 02/03/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2020
• 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: 46 YR
• Patient Sex: Male