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

Model Number 201-30300

Device Problems Overheating of Device (1437); Smoking (1585); Sparking (2595); Communication or Transmission Problem (2896)

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

Event Date 06/04/2019

Event Type  Injury  

Manufacturer Narrative

The report of the motor is captured under mfr # 2916596-2019-02820.Date of implant was requested but has not yet been provided.Approximate age of device- the centrimag console is not a single use device.Approximate age of the device from the manufacture date is not yet available.It was reported the console was removed from use.Multiple attempts for product return have been requested but the product disposition has not been provided.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported the involved console and motor were supporting a male patient.The ac power suddenly switched to battery mode, then the nurses checked the whole circuit connection and tried to plug to ac power with another power cord but failed.The console and motor were switched to backup.The switching was uneventful.Upon switching off the old console, sparks and smoke came out.The patient is stable.It was reported there were no adverse patient consequences.Another console and motor were used which resolved the issue.Additional information was requested but has not yet been provided.

Manufacturer Narrative

Manufacturer's investigation conclusions: the report of a primary console not being able to operate on ac power but only battery power was confirmed during the investigation of the returned centrimag 2nd gen primary console (sn (b)(4)).The returned console was initially evaluated and tested at the (b)(4) under work order #(b)(4).The console came in with a motor (sn (b)(4)) and a power cable (uk).Visual inspection of the console revealed damage to the rear of the console's housing.The root cause of this damage could not be conclusively determined nor correlated to the reported event.While installing the power cable, the light "on power" was not switching on.The system started on battery power, reproducing the reported issue.The console was forwarded to mcs zurich for additional testing and troubleshooting.The console was then functionally tested at (b)(4).The returned console was connected to mains power supply and switched on.The console and mains led light would not turn on under mains supply.Nevertheless, a test mag monitor was able to be powered by the console while on "battery" despite being a v1 device.A data log file was retrieved successfully.The retrieved data log file contained data captured on (b)(6) 2019 (per the timestamp) but no faults could be found.The log file showed that the console was running on battery support but without any conspicuous faults that triggered this operation.During further testing the console's 24v power supply pcb was replaced with a new one due to the no ac-operation and the console was retested on mains.Both the console and the mains led light turned on as intended after the power supply pcb replacement, indicating that the 24v power supply pcb was defective and the cause of the issue.Because the 24v power supply pcb is from an external supplier, no schematics were available at mcs zurich and no component level analysis could be performed.The root cause of the 24v power supply pcb being defective could not be conclusively determined during the investigation.After the 24v power supply pcb was replaced the console operated as intended.However, the console's software could not be updated because two of its internal pcbs (lmcebpx and ifd pcbs) were old hardware revision and were not fitted with the right connectors for the software update.Because the console was already 9 years old, it was decided to not update the hardware but instead to take it out of use.The unit was clearly marked with "scrap" stickers and was scrapped in the system.The root cause of the 24v power supply pcb being defective could not be conclusively determined during the investigation.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.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• 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: 8709719
• MDR Text Key: 148406533
• Report Number: 2916596-2019-02819
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140894
• UDI-Public: 7640135140894
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Device Catalogue Number: 201-30300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2019
• 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
• Patient Outcome(s): Required Intervention