MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE

Model Number 201-30300

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/23/2019

Event Type  Injury  

Manufacturer Narrative

Reference mfr medwatch report # 2916596-2019-00417 for the submission on the motor.The primary console is not a single use device.Approximate age of the device will be provided with the device evaluation results.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 during an extracorporeal membrane oxygenation (ecmo) procedure, the console indicated a system alert (s3) alarm.The healthcare professional pressed the alarm acknowledgement button but alarm did not resolve.The console and motor were exchanged to the backup equipment.No further information was provided.

Manufacturer Narrative

Section d10, h3, h4, h8: additional information section h1: correction.Manufacturer's investigation conclusion: the reported event of a s3 alarm was not confirmed.The centrimag console (serial #: (b)(6) was returned for analysis at (b)(6) and was evaluated.A test monitor was connected to the returned console and the console was connected to mains supply.The log file was downloaded for review.A review of the downloaded log file contained no notable events.The reported event was overwritten.The reported s3 alarm was unable to be reproduced and the returned and associated console was able to operate the motor at speed between 500 rpm ¿ 5500 rpm with a flow of 9 lpm.The console was able to operate on both battery and mains power.The console always operated as intended and no s3 alarms occurred at any time.The console was reprocessed according to the repair and maintenance procedure.The console¿s battery pack (serial #: (b)(6) had expired on 30apr17 and was replaced with a new one (serial #: (b)(6)).A new pouch was attached.The console passed all tests, including the electrical safety test.The root cause for the reported s3 alarm 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
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8295504
• MDR Text Key: 134744906
• Report Number: 2916596-2019-00533
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2019
• Initial Date FDA Received: 02/01/2019
• Supplement Dates Manufacturer Received: 08/27/2019
• Supplement Dates FDA Received: 08/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MOTOR, SERIAL # (B)(6).; MOTOR, SERIAL # (B)(4)
• Patient Outcome(s): Life Threatening