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

Model Number 201-90411

Device Problems Failure to Power Up (1476); Infusion or Flow Problem (2964); Insufficient Information (3190); Noise, Audible (3273)

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

Event Date 08/04/2023

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

It was reported that a centrimag 2nd generation primary console failed its yearly functional checkout by failing its power on test.Additionally, only 1 out of 2 speakers were producing a tone.A s3 alert was observed on the console screen.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-xxxxx.The mfr number should have been fei-based with the 10-digit fei being (b)(4).Sections a1-a4: there was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of an s3 alarm and one speaker not functioning was confirmed.The centrimag 2nd generation primary console (serial number: (b)(6) was returned and a log file was downloaded for review which showed events spanning approximately 7 days (27nov2022 ¿ 28nov2022, 02dec2022, 05dec2022, 07dec2022, 22dec2022, 23jun2023, 03aug2023 per time stamp).Events occurring on 03aug2023 took place during lab testing at abbott.On 03aug2023 a ¿system alert: s3¿ alarm was active, triggered by the sub fault ¿sf_sps_speaker_current_2¿.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was returned to the service depot and during functional testing it was found that the console was unable to pass the power on test due to only one of the two speakers functioning which was accompanied by an s3 when powered on.The nonfunctional speaker was replaced and as a precaution the second speaker was replaced as well.The replaced speakers were forwarded to the product performance engineering (ppe) testing area for further analysis where it was confirmed that only one speaker was found to function as intended.No further testing was performed.The root cause of the s3 alarm was conclusively due to the audio transducer of the centrimag console becoming electrically compromised; however, a root cause for the compromise was unable to be conclusively determined through this investigation.He 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, table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including s3 alarms.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 quality assurance (qa) specifications.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 CA CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17599758
• MDR Text Key: 321747603
• Report Number: 2916596-2023-05930
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 10/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 201-90411
• Device Lot Number: 7884659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/25/2019
• 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