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

Model Number 201-30105

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2020

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusions: the reported event of a s3 alarm was confirmed via the log file.The centrimag flow probe (serial #: (b)(4)) was returned for analysis and a log file was downloaded from the returned and associated centrimag 2nd generation primary console (serial #: (b)(4)).A review of the downloaded log file showed that the flow had dropped to 0 lpm on (b)(6) 2020 at 16:31 following a tech: sub fault fail ¿sf_flow_sensor_disconnected¿.The flow remained at 0 lpm and the tech: sub fault fail ¿sf_flow_sensor_disconnected¿ occurred several times until a s3 alarm occurred on (b)(6) 2020 following a tech: flow error ¿calibration table of the sensor not consistent¿.There were no other notable alarms active in the log file.The flow probe had a bent pin in the connector and the flow probe was subsequently scrapped.No further troubleshooting was performed.The root cause of the reported event was unable to be conclusively determined through this analysis; however, the bent pin in the flow probe connector has the potential to cause the reported alarm.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." 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." section 12.1 entitled "appendix i ¿ primary console alarms and alerts" contains a list of console alarms and alerts, as well as appropriate operator response to these events.The 2nd generation centrimag system operating manual has an emergency/troubleshooting section for the 2nd generation console.The recommended practice whenever there is a 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 back-up motor and console.Switch all components (console, motor, flow probe and cables) simultaneously to continue patient support, and then perform troubleshooting on the non-functioning system, when it is no longer being used for patient support.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that while transporting the patient, there was an audible s3 alarm.The pump did not stop.The console, motor, and flow probe were exchanged.There have not been any other issues related to the s3 alarm since the equipment was exchanged.No further information was provided.

• 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: 10240118
• MDR Text Key: 198543172
• Report Number: 3003306248-2020-00059
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 7640135140108
• UDI-Public: (01)7640135140108
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2020

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: Health Professional
• Device Model Number: 201-30105
• Device Catalogue Number: 201-30105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1