MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 201-90052

Device Problems Device Difficult to Setup or Prepare (1487); Pumping Stopped (1503)

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

Event Date 01/04/2023

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 the patient had a brief pump stop on the night of on (b)(6) 2023.Both times the pump stop was resolved by someone pushing the blood pump into the centrimag motor tighter.The ventricular assist device (vad) coordinator reviewed the alarms and checked the pump but no obvious issues were found.The patient was switched to a backup console and motor and there have been no issues since then.The patient was stable and there were no changes to patient status either before or during the event.Reference mfr for the associated motor: 3003306248-2023-00008.

Manufacturer Narrative

D4: device serial/lot number could not be provided.Manufacturer's investigation conclusion: review of the submitted log file confirmed f2 (flow signal interrupted) and f3 (flow below minimum) alarms; however, the reported pump stop was unable to be confirmed through the submitted images or the log file.A specific cause for the f2 and f3 alarms could not be conclusively determined through this evaluation.The report that the pump had to be pushed into the motor tighter to resolve a pump stop was unable to be confirmed through this evaluation, and a specific cause for the reported issue was unable to be determined.It was noted by the vad coordinator from the account that the timestamp in the log file was incorrect, and that the log file was downloaded on (b)(6) 2023, the day of the event.The final 2 days of data in the log file ((b)(6) 2022 ¿ (b)(6) 2022 per timestamp) were reviewed to ensure the reported event would have been captured in the reviewed data.Flow signal interrupted: f2 and flow below minimum: f3 alarms were intermittently captured on (b)(6) 2022 and (b)(6) 2022 while the flow minimum threshold was set to 0.75 liters per minute (lpm).There were no motor alarms to indicate a stop.The system appeared to be operating as intended.The pedimag pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The us centrimag blood pump instructions for use (ifu) (rev.09) is currently available and provides the following warnings and cautions: ifu warning #10: frequent patient and device monitoring is recommended.Ifu warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Ifu warning #16: as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.Ifu warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #8: ensure the pump is properly locked into the motor per the instructions for use supplied with the motor.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled ¿pump setup and operation¿ provides instructions for how to mount the blood pump on the motor.The following instructions are provided: to mount the pump on the motor, remove the pump from the inner tray and insert the pump into the motor receptacle.Place the bottom of the pump into the motor receptacle with the outlet port positioned in the large groove.Match the grooves on the periphery of the pump with the fittings on the motor receptacle.Rotate the pump counterclockwise until the pump locks securely into place.Thread the retaining screw clockwise to secure in place.The pump must be fully seated into the receptacle to function properly.The section titled ¿emergency backup equipment¿ states that a backup sterile pump and supplies to prime must be available.The 2nd generation centrimag system operating manual (rev.M) 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." section 12.1 entitled "appendix i ¿ console alarms and alerts" in this ifu contains a list of console alarms and alerts, including the f2 and f3 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: the patient had been on pedimag support since (b)(6) 2022.The pump stop had been observed by a nurse in the room, and they had also heard the pump stop alarms.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 16272846
• MDR Text Key: 309272538
• Report Number: 3003306248-2023-00009
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140634
• UDI-Public: 07640135140634
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090051
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90052
• Device Catalogue Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• 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
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 7 KG