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

Model Number 201-30300

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2020

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

Related manufacturer reference number: 3003306248-2020-00027.It was reported that the patient had a heartware lvad system on (b)(6) 2020 and due to right ventricle failure a temporary rvad support with centrimag system was implanted.On (b)(6) 2020 the icu staff identified a partially low flow alarom on the hvad followed by a partially low flow alarm and m4 error code sign on the centrimag console.This happened about 4 times from 14.00-18.00.Both alarms appeared together with the heartware hvad low flow alarm and the icu team noticed that the alarm appeared first by the centrimag console.The physicians changed the system to the back-up console and motor.The alarm stopped.

Manufacturer Narrative

Section g3: correction.Section d10, h3, h4: additional information.Manufacturer's investigation conclusion: the reported event of m4: motor alarms was confirmed; however, it was revealed that the centrimag console was unrelated to the cause of the event.The returned centrimag console was functionally tested on 28may2020 and was found to perform as intended.The serviced and tested console was returned to the customer site after passing all tests per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motor.The motor¿s evaluation along with the log file associated with this event have been addressed.Review of the device history record for centrimag motor showed the device was manufactured in accordance with manufacturing and qa specifications.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: 10010020
• MDR Text Key: 193306305
• Report Number: 3003306248-2020-00026
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, OUS
• Patient Outcome(s): Required Intervention