MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problem Insufficient Information (3190)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  Injury  

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 while transporting the patient, there was an audible s3 alarm.The pump did not stop.The console, motor, and flow probe were exchanged.No further information was provided.This report addresses the console.The motor is reported under mfr.#3003306248-2020-00013.

Event Description

Additional information: there have not been any other issues related to the s3 alarm since the equipment was exchanged.

Manufacturer Narrative

Section b5, d10, h3, h4: additional information.Manufacturer's investigation conclusions: the reported event of a s3 alarm was confirmed via the log file.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded from the console for review which showed that the flow had dropped to 0 lpm on (b)(6) 2020 at 16:31 following a tech: sub fault fail ¿sf_flow_sensor_disconnected¿.The flow remained at 0 lpm and the tech: sub fault fail ¿sf_flow_sensor_disconnected¿ occurred several times until a s3 alarm occurred on (b)(6) 2020 following a tech: flow error ¿calibration table of the sensor not consistent¿.There were no other notable alarms active in the log file.The centrimag 2nd generation primary console was evaluated and tested and functioned as intended.The reported alarm was unable to be reproduced during the investigation.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 9834655
• MDR Text Key: 189323078
• Report Number: 3003306248-2020-00014
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• 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: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90401
• Device Lot Number: 6704383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention