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

Model Number 201-90411

Device Problem Use of Device Problem (1670)

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

Event Date 03/15/2019

Event Type  malfunction  

Event Description

The patient was implanted with a pedimag right ventricular assist device (rvad) on (b)(6) 2019.The patient reportedly experienced a b4 battery maintenance required alarm on the centrimag console serving as the rvad.The patient was switched to backup console, motor, and flow probe on (b)(6) 2019.It is reported that the patient is doing well on the backup and no issues occurred during the swap.No additional information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: additional information: approximate age of device: 3 year, 1 month.The reported event of a b4 battery maintenance alarm was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(4)) was not returned for analysis and no log files were submitted for review.The 2nd generation centrimag system operating manual (doc.#pl-0047, rev.08) section 9.4.1 entitled ¿battery maintenance procedure¿ provides detailed instructions on how to perform battery maintenance.The root cause for the 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
• 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: 8465348
• MDR Text Key: 140509957
• Report Number: 2916596-2019-01293
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 06/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 20