MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; PRIMARY CONSOLE, RENTAL

Catalog Number L201-90411

Device Problem Infusion or Flow Problem (2964)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: the product information and disposition of the centrimag blood pump and motor was not provided but will be requested.The user facility report #(b)(4) is attached to this submission.Approximate age of device ¿ the centrimag console is not a single use device.Approximate age of the device is not known at this time as the manufacture date of the console is not available.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 biventricular extracorporeal circulatory support at an unspecified date.It was reported that the centrimag system produced a system alert (s3) and a set pump speed not reached alert (m5).Per report from staff, the pump had no flow during this period.The patient was switched over to a different centrimag console and motor.A user facility report (uf report#(b)(4)) for this event was received on (b)(6) 2018 stating: "patient is centrally cannulated with centrimag with oxygenator.Centrimag began alarming s3 and m5.Flows dropped on screen.Mcs rn told patient rn to get cca.Mcs rn grabbed backup centrimag.Charge nurse also assisted in helping getting backup centrimag attached.Patient was probably flowless for 2-3 minutes.Cca arrived and we were able to get flows back to 6-5.9 lpm.Patient did become hypotensive during this event but once flows were achieved patient recuperated.Perfusion notified of system failure.2 more backs up brought from operating room.".

Manufacturer Narrative

Investigation summary: the reported s3 and m5 alerts as well as flow readings of 0 lpm were confirmed through the evaluation of the log file data downloaded from the returned centrimag 2nd generation primary console, serial number (b)(4); however, no device-related issues were discovered during the evaluation of the returned primary console and a specific cause for the reported event could not be conclusively determined through the investigation of the returned device.It was reported that the centrimag system produced s3 (system alert) and m5 (set pump speed not reached) errors while supporting a patient.At the time the alerts were active, there was reportedly no flow displayed.The motor was reportedly making a loud ¿whirring¿ noise and was very hot to the touch.An exchange was made to a new console and motor and the alarms subsequently resolved.The log file retrieved from the 2nd generation primary console, serial number (b)(4), contained data from the time of the reported event from 03nov2018 ¿ 04nov2018, according to the timestamp.At the time of the reported event, the console was operating a motor at approximately 4400 rpm with a flow of approximately 6 lpm.On 04nov2018 at 7:12 pm, the log file captured an active s3 (system alert) alert followed by a reduction in pump speed to approximately 3200 rpm and an active m5 (pump speed not reached) alert.During this event, the flow reading reduced to 0 lpm.Pump speed remained at approximately 3400 rpm with a flow reading of 0 lpm until the motor was disconnected and the pump was removed from the system at 7:17 pm.During the s3 and m5 alerts, no full pump stoppage events occurred.The console continued to support the system but at a reduced speed of approximately 3200-3400 rpm.The returned 2nd generation primary console was evaluated by abbott technical services personnel under work order (b)(4).The reported complaint was not confirmed.The returned console was tested with the returned flow probe used during the reported event and the report of s3 and m5 alerts associated with no flow was not reproduced during testing.The unit ran for several days and no error messages were produced.No other issues were found during the evaluation of the returned components.A full functional checkout was performed and the unit passed all tests.The returned device was found to function as intended and the root cause for the reported event could not be conclusively determined.The primary console was returned to the rental pool.No further information was provided.The manufacturer is closing the file on the event.

Event Description

It was reported that patient information was not known.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE, RENTAL
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8185789
• MDR Text Key: 131123914
• Report Number: 2916596-2018-05579
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: L201-90411
• Device Lot Number: 6231492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/29/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CENTRIMAG BLOOD PUMP.; CENTRIMAG MOTOR.
• Patient Outcome(s): Other
• Patient Age: 74 YR