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

Model Number 201-90421

Device Problem Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

It was reported no patient was involved in this event.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported abbott technical services received a call stating centrimag primary console l01769-0006 received a b1 (system alert- battery module failure) alarm.Upon further investigation and testing the unit then received an s1 (power on test fail) alarm.A battery maintenance test was performed and the unit passed.The customer confirmed the unit¿s batteries were recently replaced a few months prior.The alarms have not been able to be replicated on the unit.The unit has been testing on a mock loop.It was reported no patient was involved in the event.Additional information has been requested but has not yet been provided.

Manufacturer Narrative

Section h3, h4: additional information.Manufacturer's investigation conclusion: the reported event of b1, battery module failure, and s1, power on test fail, alarms were not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6) was not returned for analysis and no log files were submitted for review.The root cause for the b1, battery module failure, and s1, power on test fail, alarms was not conclusively determined through this analysis.The reported event and subsequent investigation do not indicate an issue with the manufacture of the product.The centrimag motor instructions for use instructs the user to always have a spare centrimag motor and back-up equipment available.The 2nd generation centrimag primary console operating manual states that the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH ADULT FLOW PROBE, CAN
• 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: 8601742
• MDR Text Key: 144796717
• Report Number: 2916596-2019-02303
• 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,u
• Type of Report: Initial,Followup,Followup
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90421
• Device Catalogue Number: 201-90421
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1