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

Model Number 201-90411

Device Problems Overheating of Device (1437); Excessive Heating (4030)

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

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that a hospital requested that emergency care research institute (ecri) test a centrimag system.The following morning after the system was run overnight using a centrimag training circuit loop, the system was found at 0 rpm and alarming for motor over temperature.An infrared thermometer was used, and the motor surface temperature was measured to be 200f.A review of the datalogger data showed that the alarm was initiated around 6 hours earlier at which time an automatic motor shutdown was initiated.Despite the motor shutdown, power was thought to have continued to be delivered to the motor as it would have cooled to ambient temperature otherwise.Subsequently, ecri ran the system for three, five-day continuous runs with no stoppages and no overheating episodes.Temperature monitoring of the circulating water revealed that heat from the motor transferred to the disposable circuit.The ecri problem reporting system hazard reporting reported that the pump motor could spontaneously become hot enough to damage blood.Related manufacturer reference number: 3003306248-2024-00428 (centrimag motor) related manufacturer reference number: 2916596-2024-01171 (centrimag pump).

Manufacturer Narrative

A1-a4: there was no patient involvement.B5: the event date was estimated.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

Manufacturer Narrative

Manufacturer's investigation conclusion: a specific cause for the reported event could not be conclusively determined through this evaluation, and a direct correlation between the reported event and the centrimag 2nd generation (gen.) primary console could not be conclusively established.Multiple requests for additional information regarding this event were submitted to the contact from ecri; however, no response has been received at this time.The centrimag 2nd gen.Primary console was not returned to abbott for evaluation.The centrimag circulatory support system operation manual warns that ¿one additional centrimag console, motor and flow probe are required as backup components in the immediate vicinity of each patient whenever the centrimag or pedimag pump is used.¿ the operation manual contains a list of console alarms and alerts as well as the appropriate operator response to these events.When a motor over temp alert (m6) is captured, switch to backup console, motor and flow probe.Verify that the backup motor stands free and is not covered (e.G.Blankets).The operation manual warns ¿do not restart the pump if it has stopped due to motor overheating.Overheating is confirmed by a motor over temp alert message and temperature sufficient to prevent the user from placing and holding a hand on the motor housing.¿ follow the applicable instructions to switch to the backup system and resume support.The device history records for the centrimag 2nd gen.Primary console were unable to be reviewed due to the serial number being unknown.The centrimag circulatory support system operation manual is currently available.Section 4 entitled "warnings & precautions" warns ¿one additional centrimag console, motor and flow probe are required as backup components in the immediate vicinity of each patient whenever the centrimag or pedimag 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.¿ section 10 entitled "emergency and troubleshooting" states that "the recommended practice whenever there is a console or motor malfunction is to replace the console and motor as a set.Remove the pump from the malfunctioning motor and console and place the pump in the backup motor and console to continue patient support.Do not exchange individual motors or individual consoles during patient support." section 12.1 entitled "appendix i ¿ console alarms and alerts" contains a list of console alarms and alerts as well as the appropriate operator response to these events.When an m6 motor over temp alert is captured, ¿switch to backup console, motor and flow probe according to the procedure described in section 10.1.Verify that the backup motor stands free and is not covered (e.G.Blankets).¿ several sections, including section 6 ¿specifications and general description¿, section 8 ¿system operation¿, and section 10 warn ¿do not restart the pump if it has stopped due to motor overheating.Overheating is confirmed by a motor over temp alert message and temperature sufficient to prevent the user from placing and holding a hand on the motor housing.Clamp the return tubing and switch to the backup system according to the procedure described in section 10.1.Resume support.Record the alarm message and contact your local abbott medical representative.¿ 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18759870
• MDR Text Key: 336984983
• Report Number: 3003306248-2024-00429
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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: Other,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/30/2024

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: Other
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1