MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH MAG MONITOR; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-30500

Device Problem Pumping Stopped (1503)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported that the patient came from the operating theater in the evening during the shift.The evening shift picked up the patient from the theater and arrived at work with the operating theater team.The patient was placed in the patient's place and the night shift arrived.A report was given about the patient who was approximately 1.5m away from the extracorporeal membrane oxygenation (ecmo) device and it's control screen.The ecmo started to give the same sound as when pressing the emergency stop function.The nurse walked over to the ecmo device and noticed the speed dropped to 0 rpm and as a result the flow was 0 lpm; the flow was a bit negative as well for a little while.The speed was raised immediately to get the flow up again.The patient's pressure dropped for a short while but otherwise the patient had no symptoms.The whole thing took approximately 10-15 seconds maximum and the patient was ok.After the episode, it was replaced with a backup centrimag and the incident was reported to the authorities.Related manufacturer reference number: 2916596-2024-01240 (centrimag console).Related manufacturer reference number: 2916596-2024-01239 (centrimag motor).

Manufacturer Narrative

A2-a4; patient information not provided.No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is complete.

• Brand Name: MAG MONITOR
• 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18841711
• MDR Text Key: 337526605
• Report Number: 3003306248-2024-00430
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/05/2024

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: 201-30500
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/23/2024
• Initial Date FDA Received: 03/05/2024
• 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