MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30500

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/08/2023

Event Type  malfunction  

Manufacturer Narrative

There was no patient involved in this event.The pma# provided is associated with the device¿s most recent approval.Manufacturer's investigation conclusion: the reported event of the centrimag monitor intermittently rebooting was confirmed.The returned centrimag monitor (serial number (b)(6) was received and tested at the service depot.The monitor operated alongside a mock loop for several days, and the monitor was observed to intermittently reboot while connected to its right-side port.The unit was troubleshot, and the unit¿s main printed circuit board (pcb) was determined to be the cause of the issue.The customer was provided with a new warranty replacement monitor, and this monitor was scrapped and removed from service.The centrimag monitor¿s original main pcb was forwarded to the product performance engineering (ppe) department for further analysis.The main pcb was placed within a known working test fixture and was tested for an extended period.The monitor was observed to intermittently reboot while connected through its right-side port; no issues were observed while the monitor was connected through the left-side port.The cpu module on the main pcb was separated from the main pcb and was then reconnected.Further extended testing was performed, and further atypical events were unable to be reproduced after this point.The main pcb and cpu module fully functioned as intended after the cpu module had been reattached to the main pcb.The root cause for the reported event was determined to be related to the assembly of the centrimag monitor during the manufacturing process.Similar events were previously identified and a manufacturing analysis determined that the issue was related to the cpu module and main pcb not being properly connected resulting in a loosening connection over time.The centrimag monitor assembly procedure was updated to address the issue.The returned centrimag monitor (serial number (b)(6) was manufactured before the updates were made to the assembly procedure.The mag monitor is an optional accessory for easy handling of the 2nd generation system; however, it is not necessary for the system to function.The 2nd generation centrimag system operating manual, rev.M, section 4-"warnings & 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." review of the device history record for centrimag monitor, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and quality assurance (qa) specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient's centrimag monitor would turn on and off intermittently.No other issues were reported.The customer checked the cable connections and found no issues.

Manufacturer Narrative

A1 - a4: patient information was requested but could not be provided.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: MAG MONITOR
• 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: 17546223
• MDR Text Key: 321162533
• Report Number: 3003306248-2023-05053
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

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: 201-30500
• Device Lot Number: 8326993
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2023
• Initial Date FDA Received: 08/14/2023
• Supplement Dates Manufacturer Received: 08/25/2023
• Supplement Dates FDA Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2022
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1