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

Model Number L201-90411

Device Problem Noise, Audible (3273)

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

Event Date 10/20/2018

Event Type  malfunction  

Manufacturer Narrative

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 (lvad).It was reported on (b)(6) 2018 that the following event regarding centrimag vv ecmo patient with hvad pump as lvad support and using centrimag for vv ecmo support had rattling noise and had an s3 system alert alarm observed.At the same time, the speed dropped from set speed of 4300rpm to 3500rpm.Clinicians tried to increase speed back up to 4300rpm but speed would not increase.The patient still had forward flow throughout the event.Ecmo specialists and nursing staff tried to re-seat the patient's pump motor to fix the rattling sound and clear the s3 alarm, which did not work and the reported motor noted to be very hot.The perfusionist, nursing, intensivist were all present for troubleshooting and inspected the circuit for clots in circuit but they did not see anything.Throughout the troubleshooting, the patient still had forward flow, however the pump was unable to maintain the speed of 4300rpm and s3 alarm was going off without ability to clear, while pump still made the rattling sound inside motor during the troubleshooting time frame.The team replaced the cmag motor and primary console and the flow probe to backup the system, during which time they increased vent to 100%.No issues occurred following system replacement and no further alarms were reported after exchange.No adverse effects for patient were noted by clinicians due to the reported event or due to any system replacement.No further information was provided.

Manufacturer Narrative

Manufacturing evaluation conclusion: the report of an s3 alarm and speed drop from 4300rpm to 3500rpm could not be confirmed nor reproduced during the investigation of the returned centrimag 2nd gen primary console (serial number (b)(4)).The returned centrimag 2nd gen primary console was evaluated and tested by tech service under work order # (b)(4).The reported events were not reproduced during their testing.The console was tested along with its related motor (serial number (b)(4)) and flow probe (serial number (b)(4)).No alarms or atypical events were reproduced during testing.The pump's speed always remained at the set levels with no issues.During testing it was noted that the console's battery was due for its routine maintenance.Battery maintenance was performed without any issues.The console was functionally tested per the centrimag 2nd gen primary console service process and the unit passed all tests.A data log file retrieved from the returned console contained approximately 5 days of data (dated (b)(6) 2018 - (b)(6) 2018, according to the timestamp).Throughout the log file the system supported a pump at the set speed and the log file did not capture any atypical alarms or events.The log file did not capture any events on the reported event date.The returned console was found to function as designed.As a result, the root cause of the reported issue could not be conclusively determined nor correlated to a device related issue.The tested unit was returned to the rental pool.No further information is available.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: 8180195
• MDR Text Key: 131387212
• Report Number: 2916596-2018-05683
• 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: other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: L201-90411
• Device Catalogue Number: L201-90411
• Device Lot Number: 6329351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2018
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 115