MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problem Insufficient Information (3190)

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

Event Date 07/30/2018

Event Type  malfunction  

Manufacturer Narrative

Patient initials not provided.The device was returned for investigation.The evaluation is not yet complete.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.It was reported that the centrimag (cmag) console alarmed m3 motor disconnected and m5 motor current failure at the same time.The nurse cleared the alarms, but they returned.A perfusionist was called in and switched the patient to a backup cmag console while utilizing the same motor.The alarms resolved following the console replacement.When the alarm messages were displayed on screen prior to console replacement, the pump reportedly never stopped or lost rpms.There was no adverse impact to the patient due to the event.No additional information was provided.

Manufacturer Narrative

Correction this event is being reported against the motor instead of the console.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag motor used at the time of the reported event was not returned for analysis.Per reported information, the device will not be returned and its serial number could not be determined.As a result, the reported event could not be confirmed and the 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.

Manufacturer Narrative

The device was not return.The complaint investigation determined the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7807195
• MDR Text Key: 118101796
• Report Number: 2916596-2018-03665
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/28/2019

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 Expiration Date: 09/30/2019
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Device Lot Number: 6141145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/30/2018
• Initial Date FDA Received: 08/22/2018
• Supplement Dates Manufacturer Received: 07/30/2018; 06/20/2019; 08/08/2019
• Supplement Dates FDA Received: 11/28/2018; 06/25/2019; 08/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 75