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

Model Number 201-30300

Device Problem Overheating of Device (1437)

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

Event Date 07/05/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device: unavailable, will be updated upon the manufacturer's investigation conclusion.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was being supported by an extracorporeal circulatory support pump on (b)(6) 2019.It was reported that after 8 days of extracorporeal membrane oxygenation (ecmo) on the new born patient, the centrimag monitor displayed a high temperature alarm.The motor was exchanged.No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of a m6 alarm was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(4) ) was not returned for analysis.No log files were submitted for review.The root cause for the reported m6 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 WITH EM-TEC ADULT FLOW PROBE, OUS
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8821975
• MDR Text Key: 152054120
• Report Number: 2916596-2019-03357
• 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,Followup
• Report Date: 03/05/2020

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
• Device Catalogue Number: 201-30300
• Device Lot Number: L06338
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/08/2019
• Initial Date FDA Received: 07/24/2019
• Supplement Dates Manufacturer Received: 11/06/2019; 02/10/2020
• Supplement Dates FDA Received: 11/13/2019; 03/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention