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

Model Number 201-30300

Device Problem No Display/Image (1183)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  malfunction  

Event Description

It was reported that the centrimag console screen was black.No parameters were able to be set.The device was removed from service.

Manufacturer Narrative

The event was reported as no patient involved.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: incidental findings: pcb damage the reported event of the centrimag console¿s screen not functioning as intended was confirmed.The returned centrimag console (serial number (b)(6) was observed to have a damaged display screen upon arrival.The unit was functionally tested alongside known working test equipment, and no information was displayed on the console¿s screen throughout testing.However, the console was able to operate a mock loop as intended, and the buttons on its user interface also functioned as intended despite the screen remaining blank.A log file was also extracted from the console during testing; however, no atypical events within the timeframe of the reported event (mar2023) were observed, and the console was not observed to be in patient use during this time.The centrimag console was opened and was inspected at a component level.The unit was troubleshot, and the cause of the issue was narrowed down to the unit¿s screen printed circuit board (pcb).Electrical measurements were made across the screen pcb; however, no atypical findings were observed, and the vacuum fluorescent display (vfd) screen appeared unremarkable despite the observed damage to the console¿s screen housing.Although the root cause of the reported event was narrowed down to the screen pcb, further root cause was unable to be determined.The event that resulted in the damage to the console¿s screen housing had the potential to result in the internal damage to the vfd screen as well.Review of the device history record for centrimag console, serial number (b)(6) , showed the device was manufactured in accordance with manufacturing and qa specifications.The 2nd generation centrimag system operating manual (section 3 "warnings and precautions") warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction.The 2nd generation centrimag system operating manual (section 8.3 ¿recommended preventive maintenance¿) instructs users to regularly inspect the console for signs of damage and to return the console back to thoratec for servicing if any damage is observed.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
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 16629108
• MDR Text Key: 312410826
• Report Number: 3003306248-2023-01393
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

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 Model Number: 201-30300
• Device Lot Number: L06588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/22/2023
• Initial Date FDA Received: 03/28/2023
• Supplement Dates Manufacturer Received: 06/13/2023
• Supplement Dates FDA Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1