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

Model Number 201-30500

Device Problem Unexpected Shutdown (4019)

Patient Problem Insufficient Information (4580)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2021 the centrimag monitor was hooked up in the intensive care unit (icu) to the primary and the backup console.Over the span of fifteen minutes the pump randomly stopped about five times.The box would pop up on the screen and it would begin the countdown to pump off that typically happens when pressing and holding the stop button.The monitor was disconnected and there were no console issues.Each time the pump off occurred it was able to be restarted without any delay.The monitor was hooked up again and after a short period of time it beeped and started the pump off sequence again.The monitor cable was removed immediately and the pump did not shut off the last time.Both cables were removed from the monitor cart and on (b)(6) 2021 the event was able to be replicated three times in the perfusion office.The cords were inspected for any obvious issues, and nothing notable was found.

Manufacturer Narrative

A3: multiple attempts were made to obtain the patient's gender, but no information was provided.Manufacturer's investigation conclusion: the reported event of a ¿cf¿ error and the monitor initiating a pump stop sequence was confirmed via testing.The centrimag monitor (serial #: (b)(6)) was returned for analysis and was evaluated and tested.The reported event was able to be duplicated and verified.The monitor was connected to test equipment and a mock loop.The monitor powered on as intended; however, after some time the ¿cf¿ error icon appeared.After a while the pump stopping sequence automatically began and the pump stopped.The monitor is an older version is no longer serviced or repaired.The monitor was scrapped and forwarded to product performance engineering (ppe) for further analysis.The returned monitor was connected to the lab test equipment and powered on.The monitor was left to run and after several hours the monitor displayed a ¿boot up error, system stopped¿ message on the screen.The monitor was power cycled, and the ¿cf¿ error was present on the screen.The monitor was opened to inspect the internal printed circuit boards (pcb) and connections.No anomalies were found.The compact flash card was reseated, and the monitor was closed.The monitor was powered on again; and the ¿cf¿ error was no longer present.Due to the monitor no longer being serviceable, troubleshooting could not be performed any further due to lack of parts.Multiple good faith efforts were sent to retrieve additional information regarding patient consequence; however, a response was not received.The root cause for the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed for the centrimag monitor (serial #: (b)(6)) and the monitor was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual section 4 entitled "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." the 2nd generation centrimag system operating manual section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a 2nd generation centrimag primary console or motor malfunction is to replace the console and motor as a set.Remove the blood pump from the malfunctioning motor and console and place the blood pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." although this event is not covered under abbott labelling, the 2nd generation centrimag software design description states: ¿the bottom status bar is displayed on the bottom of the monitor screen.It displays the battery statuses, the current date and time and the state of the compact flash card and usb stick.¿ ¿if the sd card is not inserted or can¿t be mounted a crossed red sd-icon beside the date indicates the warning status.No icon is displayed if the sd card is in normal operation state.¿ no further information was provided.The manufacturer is closing the file on this event.

• Brand Name: MAG MONITOR SET
• 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: 12144435
• MDR Text Key: 261939134
• Report Number: 3003306248-2021-02986
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140153
• UDI-Public: 7640135140153
• 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: 11/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 22 YR
• Patient Weight: 77