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

Model Number 201-90411

Device Problems Overheating of Device (1437); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/07/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Related manufacturer¿s report 2916596-2020-05087, 916596-2020-05088.It was reported that the centrimag console overheated and required an urgent change out to a back up.The nurse reported the pump alarming low flow and it just stopped, there was a burning smell in the room.Nothing was kinked and flow was not being limited to the pump during this time.The site was able to switch it over to the back up controller and pump but then they also reported the flow probe not reading so they were required to switch that out afterwards.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events of the centrimag system overheating / producing a burning smell, and an f3: flow below minimum alarm were not confirmed.A log file was extracted from the returned centrimag console and was reviewed.Events with a timestamp of the event date, (b)(6) 2020, were not observed throughout the data, as the earliest recorded time stamp was (b)(6) 2020 at 22:22.The console was not observed to be in patient use throughout the log file.Atypical alarms, including f3 alarms and alarms related to overheated conditions, were not observed throughout the log file.No notable events were observed.The returned centrimag console (serial number (b)(6)) was tested under work order #(b)(4 on 04nov2020 alongside the returned centrimag motor (serial number (b)(6), evaluated under (b)(4) and a known working test flow probe.Atypical events were unable to be reproduced throughout all testing.A full functional checkout was performed, and the serviced unit was returned to the customer site after passing all tests per procedure.The root causes of the reported events were unable to be 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: 10740623
• MDR Text Key: 213208457
• Report Number: 2916596-2020-05086
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 12/28/2020

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: 03/31/2022
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 7429934
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/07/2020
• Initial Date FDA Received: 10/27/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG MOTOR, US; CMAG PRIMARY CON W/ 3/8" FLWPB; CENTRIMAG MOTOR, US; CMAG PRIMARY CON W/ 3/8" FLWPB
• Patient Age: 57 YR
• Patient Weight: 104