MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH EM-TEC ADULT FLOW PROBE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30105

Device Problem Infusion or Flow Problem (2964)

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

Event Date 09/11/2022

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 during bivad centrimag support the centrimag mag monitor flow display stopped displaying values.Speed was displayed and blood flow remained to the patient.Blood flow was confirmed by attaching a separate non-cmag flow probe to the system.The cmag flow probe was exchanged which then displayed down arrows.The system received s3 codes.The console and flow probes were removed and the patient was switched to a backup system without incident.Cmag console mfr#: 3003306248-2022-12512 motor mfr#: 2916596-2022-14112.

Manufacturer Narrative

Manufacturer's investigation conclusion: the centrimag flow probe (serial#: (b)(6) was returned for evaluation with the reported event of blank flow and s3 alarms.The flow probe was returned to the service depot and was connected to a test console and functioned as intended.The reported event of blank flow and s3 alarms was unable to be correlated to an issue with the returned flow probe.The device history records were reviewed for the centrimag flow probe (serial#: (b)(6) and the flow probe was found to pass all manufacturing and qa specifications.The 2nd generation centrimag system operating manual 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 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 table 16 entitled ¿console alarms & alerts¿ addresses how to properly interpret and troubleshoot all system alarms including s3 alarms.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was later reported that the system received s3 codes.After switching the patient to the backup system, the console and flow probe were connected to a mock loop and the s3 alarms were reproduced.

• Brand Name: EM-TEC ADULT FLOW PROBE
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 15487142
• MDR Text Key: 302958565
• Report Number: 3003306248-2022-12519
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140108
• UDI-Public: 7640135140108
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30105
• Device Lot Number: 6842045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/31/2019
• 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 Sex: Male