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

Model Number 201-90411

Device Problems Insufficient Information (3190); Noise, Audible (3273)

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

Event Date 05/26/2023

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# 3003306248-2023-01940 and mfr# 3003306248-2023-01942 it was reported that a crunching, whooshing sound was heard from the centrimag followed by an alarm.The pump flow dropped to zero.The flow probe was connected well and the pump was seated well in the motor.The motor and the console were replaced with no issues and the problem resolved.

Manufacturer Narrative

Section d4: the centrimag console is serviceable equipment and does not have an applicable expiration date.Manufacturer's investigation conclusion.The reported event of the centrimag system producing an atypical sound was not confirmed; however, the reported event of an atypical alarm resulting in a blank flow reading was confirmed via the log file that was extracted from the returned centrimag console (serial number (b)(6)).An f2: flow signal interrupted alarm was observed on 26may2023, causing the patient's flow value to read as 0 lpm.This alarm cleared and immediately reactivated twice within the next few minutes and correlated to fault flags that may indicate a potential communication issue.The system was observed to have been shut down a few minutes later on the same day to perform the reported equipment exchange.The system was observed to have been powered on again a few more times on (b)(6) 2023, and similar f2 alarms continued to intermittently occur, temporarily blanking the flow value to read 0 lpm until the alarms were cleared.The returned centrimag console was functionally tested at the service depot alongside known working test equipment and alongside the other returned centrimag equipment (motor l06699-0020 and flow probe 95431, each evaluated separately) for extended periods.No atypical events or alarms were observed throughout all testing.The serviced and tested centrimag console was returned to the customer site after passing all tests per procedure.The root causes of the reported events were unable to be conclusively determined through this analysis.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 / 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 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts, including flow-related alarms, as well as appropriate operator response to these events.Review of the device history record for the centrimag console, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

The patient passed away due to cardiac arrest on (b)(6) 2023.Related manufacturer's reference number for the death: 2916596-2023-05323.

• 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: 17120297
• MDR Text Key: 317759207
• Report Number: 3003306248-2023-01941
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 5750336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 121 KG