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

Model Number	L201-90404
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Related manufacturer reference number: 3003306248-2023-05059 (centrimag motor).Related manufacturer reference number: 3003306248-2023-05060 (centrimag motor).Related manufacturer reference number: 3003306248-2023-05074 (console).Related manufacturer reference number: 3003306248-2023-05075 (console).It was reported that while supporting a biventricular assist device (bivad) patient in the operating room (or), the patient experienced simultaneous pump stoppages as both centrimag consoles went to zero rpm and zero flow.Several successive beeps sounded, and it was noted that the beeps sounded like the emergency stop button had been pushed, although no one had done so.The rpms of both systems were manually increased immediately, and flow was re-established to the patient.Both consoles were attached to centrimag mag monitor at the time of the event.It was noted that power strips, strong magnets, cell phones, fluoroscopes, and bluetooth devices were not used in close proximity and that both consoles were plugged into a red emergency hospital ac power outlet.It was advised that the mag monitor be disconnected from both consoles so that the consoles could be interfaced directly, and no further rpm disruptions were reported after disconnecting.There was no adverse patient consequence, and it was also noted that these were abbott rented systems.Log files for both consoles were sent in for evaluation.
Additional Manufacturer Narrative
Section a: patient information was requested but not provided.No further information was provided.A supplemental report will be submitted once the manufacturers investigation is complete.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the centrimag monitor was returned for evaluation following the reported event of the pump speed dropping to zero revolutions per minute.However, it was determined that the returned centrimag monitor was unrelated to the cause of the event.The returned centrimag monitor was functionally tested by service depot and the unit operated as intended throughout all testing.The serviced and tested unit was returned to the rental pool after passing all tests per procedure.It was revealed that the root cause of the reported event was related to the returned centrimag motors.The motors¿ evaluation along with the log files associated with this event have been addressed via the motor investigations (mfr.Report # 3003306248-2023-05059 and 3003306248-2023-05060).The device history records were reviewed and the records revealed that the centrimag monitor was manufactured in accordance with manufacturing and qa specifications.The centrimag 2nd gen system operating manual (rev.M) section 3.1.3 ¿ "mag monitor" states "should the mag monitor be disconnected or fail, the 2nd generation centrimag primary console may be operated independently with the relevant operational data displayed on the console display.When the mag monitor is active, control of motor and pump function may be accomplished using either the mag monitor or the console.If a mag monitor is unavailable, the pump and motor can be controlled via the 2nd generation centrimag primary console.When operated in this manner, a number of features that can only be accessed via the mag monitor will not be available.These include; stopwatch function, graphical displays of the pressure, as well as flow and alarm limits." the 2nd generation centrimag system operating manual (rev.M) section 12.1 ¿ "appendix i ¿ primary console alarms and alerts" cover all alarms (auditory and visual), and the appropriate actions to take if the issue does not resolve.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: MAG MONITOR SET
• Common Device Name: 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: 17725647
• Report Number: 3003306248-2023-05061
• Device Sequence Number: 15257138
• Product Code: DWA
• UDI-Device Identifier: 07640135140696
• UDI-Public: 07640135140696
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K131179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• Operator of Device: Health Professional
• Device Model Number: L201-90404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/22/2023
• Supplement Date Received by Manufacturer: 11/28/2023
• Initial Report FDA Received Date: 09/11/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Male