MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR; MOTOR, RENTAL

Model Number L102956

Device Problem Noise, Audible (3273)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

The motor will be returned for evaluation once the temporary replacement is received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device on (b)(6) 2018 was reported that the patient was at an outside institution where the perfusionist had just switched from one institutions equipment to the other in preparation for transport back to the hospital.The changeover went well and while waiting for the rest of the team to be ready the m3 alarm happened while still in the outside hospital icu.The perfusionist switched to the backup equipment she had brought with her.She said she heard a loud noise from the motor as well as the alarm.The patient is currently still supported on va ecmo.No other information to report at this time.

Manufacturer Narrative

The returned centrimag motor (serial number (b)(4)) was evaluated and tested by tech service under work order #(b)(4).Upon arrival the unit was inspected for any exterior damage and none was observed.The motor was connected to its associated complaint console (serial number (b)(4), evaluated under pi-2018-0150208-02) and allowed to run for several days without triggering any alarms.The reported issue could not be confirmed and the returned motor worked as intended during testing.The motor was tested per the centrimag motor service process and passed all tests.Old motor ifu was replaced with new revised version doc.#pl-0069, rev.04 as a corrective action for field action fa-q318-mcs-1.The motor was returned to the rental pool.The root cause of the reported event could not be conclusively determined during the investigation.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
• Type of Device: MOTOR, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 7871439
• MDR Text Key: 120103447
• Report Number: 2916596-2018-04046
• Device Sequence Number: 1
• Product Code: DWA
• 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
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: L102956
• Device Catalogue Number: L102956
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 116