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

Model Number 102956

Device Problems Device Alarm System (1012); Protective Measures Problem (3015); Unexpected Shutdown (4019)

Patient Problem Low Oxygen Saturation (2477)

Event Date 10/18/2021

Event Type  Injury  

Event Description

A covid positive patient's extracorporeal membrane oxygenation (ecmo) console began alarming motor fail, low flow, and motor over heated.The alarms all began simultaneously and without any warning.There were no rpms displayed and ecmo flow was shown as -0.32.Nurses, respiratory therapy, and nurse practitioner immediately donned personal protective equipment (ppe) and entered room.Upon entering, there was no movement to the ecmo motor, so the fio2 was immediately increased to compensate.The patient's o2 saturations decreased to 64% during the event which lasted a total of 6 minutes.The ecmo motor head was switched, and flow was restored along with return of oxygenation and the patient was returned to their original settings.A work order was placed for the malfunctioning ecmo motor and clinical engineer is currently running tests.The patient remains on ecmo in the critical care unit at this time.Concerns: a yellow alarm did not alarm prior to ecmo motor shut off.The ecmo motor becomes unseated and there is not an alarm that alerts of this.Design flaw: motor temperature is not displayed, therefore cannot be proactive if the motor is overheating.Manufacturer aware: called mfg and received rma# (b)(4) awaiting shipping label.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12703396
• MDR Text Key: 278557975
• Report Number: 12703396
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• 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?: Yes
• Date Report Sent to FDA: 10/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 15330 DA