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

Model Number 201-90411

Device Problems Decreased Pump Speed (1500); Insufficient Flow or Under Infusion (2182)

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

Event Date 05/28/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device ¿ the centrimag primary console is not a single use device.Approximate age of the device from the manufacturer date is 1 year 5 months.The device was returned for investigation.The evaluation is not yet complete.No further information was provided.Console mfr# 2916596-2019-02528, motor mfr# 2916596-2019-02529, flow probe mfr# 2916596-2019-02712.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 (vad) for acute support.It was reported that the patient was placed on support on (b)(6) 2019 as va (vein-artery) extracorporeal membrane oxygenation (ecmo) with rpm 5500 flow 4.8 lpm.The patient was converted to vv (vein-vein) ecmo a few hours later and maintained 5500 rpm and 4.5 lpm.The pump motor started making a louder than normal humming sound, it became physically slightly hot, & rpms.On (b)(6) 2019, system alert s3 alarm came on and dashes appeared on the lpm.Rpm dropped to 3900 rpm and set pump speed not reached alarm m5 appeared.The patient circuit & physical pump was changed at bedside.The customer clamped the circuit and rebooted the system and reinitiated support.The set speed of 5500 dropped to 4900 rpm with dashes on lpm and the system alert s3 appeared.The customer switched to backup system and resumed support.It was determined by biomed & the perfusion department that the centrimag motor was exhausted due to the large amount of resistance induced by a very small outflow cannula size (15 fr), given that the rpm was maxed out at 5500 rpm, and the patient was very large (145 kg).Equipment was exchanged, disposables including centrimag changed, & eventual reduction of rpms and removal from ecmo support.Patient successfully removed from ecmo support on (b)(6) 2019.

Manufacturer Narrative

Section h3 and h4: additional information.Manufacturer's investigation conclusion: the reported events of a system alert: s3 alarm and a set pump speed not reach: m5 alarm were both confirmed via a log file extracted from the centrimag 2nd gen.Primary console during testing.Per the log file, on (b)(6) 2019 at 00:47, the log file captured an active system alert: s3 as a result of an active sf_ifd_shutdown_detected fault.However, m5 alarms were also active before the sf_ifd_shutdown_detected fault, occurring as early as 00:43 of that day ¿ the pump speed was ~4800 rpm right before that fault.After this event, speed dropped to ~3900 rpm and flow reading would have been blank with "--.--" on the console display, consistent with the reported information.A set pump speed not reached: m5 alarm was captured within the same minute, and m5 alarms continued to appear throughout the remainder of data captured on (b)(6) 2019.Flow values continued to show 0 lpm until the console was shut down and restarted.System alert: s3 alarms did not occur after the first instance.The console was forwarded to the service depot for further testing.The centrimag 2nd gen.Primary console (serial number (b)(6)) was tested under a work order on 02aug2019.The reported event was not verified or duplicated.The console was operated for an extended period of time with the returned motor (s/n (b)(6)), monitor (s/n (b)(6)), and flow probe (s/n (b)(6)).The console was also operated with test centrimag equipment.No s3 alerts or any other error messages occurred throughout testing, and additional issues were not observed.A full functional checkout was performed and the unit passed all tests.The returned console was found to function as intended.As a result, the reported event could not be correlated to a console related issue.The serviced and tested unit was returned to the customer site.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section g1: correction.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8697157
• MDR Text Key: 148003285
• Report Number: 2916596-2019-02528
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2020
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6329351
• Was Device Available for Evaluation?: Yes
• 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: 40 YR
• Patient Weight: 145