MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, OUS

Model Number 201-10002

Device Problem Device Stops Intermittently (1599)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/31/2018

Event Type  malfunction  

Manufacturer Narrative

This medwatch is reporting motor (b)(4).The device is expected to be returned for analysis.It has not yet been received.The event occurred at (b)(6) hospital (b)(6).No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2018.It was reported that after converting to mains power, a "system alert: s3" alarm occurred on the primary console, and the flow disappeared on the display leaving only "dash" marks.Flow was still visible in the circuit.Initial re-positioning and disconnection/re-connection of flow probe did not resolve the issue.The backup primary console was powered up and the flow probe was connected to circuit.Initially, this showed flow on the display, but quickly disappeared to show the same error code and dash marks for flow.The backup primary console was powered down, left for approximately 20 seconds, re-powered, and the error code resolved.The circuit was moved to the backup primary console without event.Flow was displayed and no repeat of error occurred.No other events occurred.Reportedly, the patient did not suffer any hemodynamic compromise due to the event.No additional information was provided.

Manufacturer Narrative

The report of an s3 alarm was confirmed through a submitted picture, which showed an s3 alarm active on the primary console.The specific primary console on which this alarm occurred could not be determined from the picture nor could the cause of the alarm.The reported complaint could not be verified nor reproduced during testing.The motor was tested with related primary console serial number (b)(4) that was returned under the same complaint (refer to medwatch mfr report # 2916596-2018-02269 for the primary console).While running the unit, the motor did not trigger any error messages.No flow issues or error messages were reproduced during testing.The motor cable was inspected and no issues were observed.A full functional checkout was performed and the motor passed all tests.The motor was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined.Reports of similar events will continue to be tracked and monitored.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, OUS
• Type of Device: MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7578371
• MDR Text Key: 110463147
• Report Number: 2916596-2018-02271
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-10002
• Device Catalogue Number: 201-10002
• Other Device ID Number: 7640135140061(
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1