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

Model Number 201-30300

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2019

Event Type  malfunction  

Manufacturer Narrative

The associated centrimag 2nd generation primary console, sn: unknown is reported under mfr # 2916596-2020-00893 and the associated centrimag motor, ous, sn: (b)(4) is reported under mfr # 2916596-2020-00892.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that there was an s3 alert on the console while the system was in use on a patient in an ambulance en-route to the hospital.There was also no flow probe reading.The back-up console was attached and initially got a reading.However, then the same s3 alert appeared and the flow probe did not have a reading.The device was detached from the ambulance power supply and turned off and on.Following that the flow probe worked fine for the duration of the journey.There were no adverse patient effects.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of an s3 alarm was confirmed.A log file was extracted from the returned centrimag console and was reviewed.The system operated at speeds around the set speed throughout all data observed on the event date, (b)(6) 2019.A can bus error sub-fault was observed on (b)(6) 2019 at 18:50, causing the reported s3 alarm.Flow readings were observed to be 0 lpm after the observed s3 alarm due to the can bus error sub-fault.The s3 alarm was observed to have been muted at 18:51 and did not reoccur throughout the remainder of the log file.No other notable events were observed.The returned centrimag console (serial number (b)(6)) was functionally tested on (b)(6) 2020.The console was found to perform as intended, and no atypical events occurred throughout all testing.S3 alarms caused by a can bus error sub-fault were stated to resolve upon power cycling the console.The console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.Reports of similar events will continue to be tracked and monitored.Review of the device history record for centrimag console s/n (b)(6) showed the device was manufactured in accordance with manufacturing and quality assurance 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 CH-80 05; SZ CH-8005
• MDR Report Key: 9748437
• MDR Text Key: 182444429
• Report Number: 2916596-2020-00891
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 7640135140894
• UDI-Public: (01)7640135140894
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

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 Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/24/2020
• Supplement Dates Manufacturer Received: 05/27/2020
• Supplement Dates FDA Received: 06/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1