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

Model Number 201-90411

Device Problem Pumping Stopped (1503)

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

Event Date 01/11/2020

Event Type  malfunction  

Manufacturer Narrative

Multiple attempts for this information were made however no response was 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 a centrimag unit being used for vv ecmo was stopping intermittently and had to switch to the backup unit.Revolutions per minute(rpms) went to 0 with 0 flows and immediately increased back to the set value of 5500.This happened again within a few minutes.The motor was not spinning during both incidents.Patient's spo2 (oxygen saturation) decreased to the 80's briefly.The doctor switched to the backup system.Patient's heart rate briefly decreased to the 40's.No further information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a centrimag system stopping intermittently could not be confirmed during the investigation.The centrimag 2nd gen primary console and motor used during the reported event were not returned for analysis.Multiple attempts to obtain the product along with additional information were unsuccessful.Additionally, no log files were submitted for this event.As a result, the reported event could not be confirmed and its root cause could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.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: 9644127
• MDR Text Key: 179450435
• Report Number: 2916596-2020-00291
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Weight: 90