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

Model Number 102956

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  

Event Description

It was reported that the patient had a brief pump stop on the night of (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 blood pump: 3003306248-2023-00009.

Manufacturer Narrative

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

Manufacturer Narrative

Section d4: the serial number of the motor was unknown but was thought to be either (b)(6); (b)(6); or (b)(6).Manufacturer¿s investigation conclusion: the reported event of the pump stopping due to the pump and motor not being fully engaged was not confirmed.No motors (serial number: either (b)(6), (b)(6), or (b)(6)) were returned for evaluation; however, log files were downloaded from the console and submitted for review.The submitted log file contained data spanning approximately 48 days (08aug2022 to 25sep2022 per time stamp), and no events were captured on the reported event date of 04jan2023.Throughout the data, the motor maintained steady values at the set speed and no pump stops were observed.Provided information indicated that the pump stops resolved temporarily when the pump was pressed tighter into the centrimag motor.It was also communicated that the issues resolved fully following the replacement of both the motor and console.The root cause of the reported event could not be conclusively determined via this analysis.The device history records were reviewed for the centrimag motor (serial #: (b)(6)), and the motor was found to pass all manufacturing and quality assurance specifications.The device history records were reviewed for the centrimag motor (serial #: (b)(6)), and the motor was found to pass all manufacturing and quality assurance specifications.The device history records were reviewed for the centrimag motor (serial #: (b)(6)), and the motor was found to pass all manufacturing and quality assurance specifications.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.".The 2nd generation centrimag system operating manual (rev.M) 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.".The 2nd generation centrimag system operating manual (rev.M) table 16 entitled ¿console alarms & alerts¿ addresses how to interpret and troubleshoot all system alarms including those associated with motor stop and flow signal interruption conditions.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• 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: 16272847
• MDR Text Key: 309077002
• Report Number: 3003306248-2023-00008
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• 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: 03/08/2023

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: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 6 MO
• Patient Sex: Male
• Patient Weight: 7 KG