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

Model Number L102956

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device- n/a.The device is expected to be returned for evaluation.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

No patient was involved in this event.It was reported the centrimag 2nd generation primary console and motor displayed an m3 pump not inserted alarm.The product will be returned for evaluation.No additional information was provided.

Manufacturer Narrative

Section a1, a2, a3, a4, d6: no patient was involved in the event.Section b1, b5, d5, h3: additional information.Section f9: approximate age of device- the centrimag motor is not a single use device.Approximate age of the device from the manufacture date is 9 months, 10 days manufacturer's investigation conclusion: the reported event of error codes m3 and f2 being displayed by the console and the motor is not confirmed.The centrimag motor (serial #: (b)(4) was returned to the service depot for analysis.The returned centrimag motor was evaluated and tested under work order # (b)(4).The service depot was unable to confirm or duplicate the reported m3 and f2 error codes.A full functional checkout was performed, and no error codes were received at any point.The motor cable was inspected per field action (b)(4), and no issues were found with the motor cable.The unit passed all tests.The root cause for the reported event of error codes m3 and f2 being displayed by the console and the motor was not conclusively determined through this analysis.Centrimag motor instructions for use (doc.#pl-0069, rev.04) states that if the unit fails to operate according to the motor specifications or a console diagnostic error indicates a centrimag motor malfunction, it should be returned.Additionally, this document instructs to always have a back-up centrimag motor and back-up equipment available.It also instructs the user to inspect the centrimag motor, cable, console connector, and locking mechanism for any damage prior to use.If any component is damaged, do not use the centrimag motor.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information from the clinician reported before this incident, the perfusion team had not reported any previous problems with the equipment.No patient was involved with the event.No additional information was provided.

Manufacturer Narrative

Section d3, g2: correction.

• Brand Name: CENTRIMAG MOTOR
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8303160
• MDR Text Key: 135000037
• Report Number: 2916596-2019-00463
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1