MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number L201-90411

Device Problems Insufficient Information (3190); Noise, Audible (3273)

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

Event Date 08/23/2018

Event Type  malfunction  

Manufacturer Narrative

A supplemental report will be submitted once the manufacturers 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 reported event could not be confirmed nor reproduced during testing of the returned centrimag 2nd generation primary console (serial number (b)(4)).The returned console was evaluated and tested by tech service under work (b)(4).Upon arrival the unit was inspected for any exterior damage and none was observed.The console was connected to its associated complaint motor and allowed to run for several days without any alarms being triggered.The reported issue could not be confirmed and the unit worked as intended.The console was tested per the centrimag 2nd generation primary console service process and it passed all tests.The unit was forwarded to the rental pool.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 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 7866463
• MDR Text Key: 120121400
• Report Number: 2916596-2018-04048
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• 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,Followup,Followup
• Report Date: 03/04/2020

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: Lay User/Patient
• Device Expiration Date: 09/30/2020
• Device Model Number: L201-90411
• Device Catalogue Number: L201-90411
• Device Lot Number: IFS100274
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2018
• Initial Date FDA Received: 09/11/2018
• Supplement Dates Manufacturer Received: 08/23/2018; 11/16/2018; 02/26/2020
• Supplement Dates FDA Received: 09/13/2018; 12/05/2018; 03/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 116