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

Model Number 201-90411

Device Problem Overheating of Device (1437)

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

Event Date 06/15/2019

Event Type  Injury  

Manufacturer Narrative

The device was returned for investigation.The evaluation is not yet complete.Approximate age of device - the centrimag primary console is not a single use device.Approximate age of the device is calculated from the manufacture date.Manufacture date was not provided.Age of device will be added in a supplemental report.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported that the patient had been on veno-venous (vv) cardiopulmonary support (cps) for 5 days.They received a motor overheat alarm and switched to the back up console patient was placed on veno-venous (vv) extracorporeal membrane oxygenation (ecmo) support on (b)(6) 2019 for acute respiratory failure due to diffuse alveolar hemorrhage.Patient received 5000 units heparin intravenous pyelogram (ivp) as bolus upon ecmo initiation and was started on heparin drops for ecmo day 1 that was subsequently stopped on ecmo day 2 due to airway bleeding.On vv ecmo day 5 ((b)(6) 2019), centrimag console had an m6 alarm at which point the patient was switched to the backup console with no complications and no hemodynamic changes.On vv ecmo day 6 ((b)(6) 2019), ecmo specialist (es) received a called from the ecmo bedside nurse stating the centrimag console was alarming and not flowing.Es arrived in room and noticed the patient hemodynamics deteriorating (peripheral capillary oxygen saturation (spo2 10%) and centrimag console screen was displaying "0 rpm" / "0 flow" with error messages m2 (motor disconnected), f2 (flow signal interrupted).At this point, es confirmed patient was not receiving ecmo support and immediately began the process to switch to the back-up console.Es re-established ecmo flow and patients hemodynamics recover quickly (spo2 now 90%).The m6 alarm was due to clot in the pump housing.Patient decompensated and required intervention to sustain life.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a motor overheat alarm was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console.Per the log file, on the reported event date of (b)(6) 2019 the console was supporting a system at a speed of ~3900rpm and a flow of ~4.15lpm for over 112 hours.At approximately 5:38pm on (b)(6) 2019 the log file captured an active motor over temp:m6 alarm, confirming the reported event.This alarm did not affect the console's ability to support the pump at the set speed and flow reading did not change.At approximately 5:51pm the speed setting was changed to 0rpm, and the system responded as designed.The m6 alarm cleared approximately 1 minute later.Soon after, the pump and flow probe appeared to be disconnected and the system was powered down at approximately 5:54pm.On (b)(6) 2019 the console was operated with a system for over 1.25 hours and supported the motor and pump at the set speed without any issues.Each time speed was adjusted the console responded as designed.The root cause of the m6 alert could not be determined from the log file analysis.The returned centrimag 2nd gen primary console ( was evaluated and tested by the service depot.The reported complaint could not be verified during their evaluation.The console was tested along with its associated motor and flow probe.No atypical alarms or events were reproduce during testing.Full functional checkout was performed per the centrimag 2nd gen primary console service process and the unit passed all tests.A successful routine battery maintenance was performed to the console's battery.The returned console was found to function as intended.As a result, the root cause of the reported event could not be conclusively determined nor correlated to a console related issue.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: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8744271
• MDR Text Key: 149514468
• Report Number: 2916596-2019-02923
• 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
• Report Date: 10/08/2019

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: 01/31/2021
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6832584
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/15/2019
• Initial Date FDA Received: 06/28/2019
• Supplement Dates Manufacturer Received: 08/22/2019; 10/07/2019
• Supplement Dates FDA Received: 09/09/2019; 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 20 YR
• Patient Weight: 75