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

Model Number 102956

Device Problem Pumping Stopped (1503)

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

Event Date 08/29/2023

Event Type  malfunction  

Event Description

It was reported that the patient had a blood pump exchange with oxygenator removal on (b)(6) 2023.On an unidentified date the patient was on support and had a brief pump stop where the speed and flow both went to 0 simultaneously for a couple of seconds and then returned to baseline without intervention.Once it occurred twice on the patient, the motor, console, and flow probe were exchanged and sent for evaluation but came back good.The same thing happened again on (b)(6) 2023.The patient's speed and flow went to 0 for reportedly 6 seconds and then back to baseline.The nurse reported that the pump running sound disappeared as if it truly stopped during that time.No hemodynamic changes were noted.Flow went back up to baseline without intervention from the nursing staff.The customer reported that the only constant through multiple events was the patient's pump.The customer also noted that the pump was more "loose" than previous pumps.No adverse consequences were reported and the patient remained stable on the same pedimag.Related manufacturer reference number for the exchanged console: 3003306248-2024-00028, related manufacturer reference number for the loose pump: 3003306248-2024-00001, related manufacturer reference number for the exchanged pump: 3003306248-2024-00021, related manufacturer reference number for the second motor: 3003306248-2024-00002, related manufacturer reference number for the second console: 2916596-2024-00137.

Manufacturer Narrative

Section d4: serial number was requested but has not been provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• 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: 18584084
• MDR Text Key: 334781855
• Report Number: 3003306248-2024-00027
• 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
• Report Date: 01/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model 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: 12/29/2023
• 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: 5 KG