MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90401

Device Problems Erratic or Intermittent Display (1182); No Display/Image (1183); Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem Blood Loss (2597)

Event Date 11/07/2019

Event Type  Injury  

Manufacturer Narrative

This report addresses the console.The motor is reported under mfr.#2916596-2020-00790.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient was on extracorporeal membrane oxygenation (ecmo) support while in surgery.The console alarmed that the pump was stopped, which was followed by low flow and low pressure alarms.The perfusionist noticed that the speed was zero rotations per minute (rpm), that flow had stopped and that retrograde flow was evident.The ecmo delivery line was clamped to prevent further retrograde flow and the perfusionist pressed the speed increase button to 2000 rpm, which restarted and sped up the pump.The clamp was removed and the speed was further increased.The perfusionist attempted to access the console log but the log would not display on the screen.The log screen flashed momentarily before switching back to the main screen; this happened 3 or 4 times.The console was exchanged.The motor and flow probe were not exchanged and there were no further problems.The log screen on the backup console displayed as expected.The patient was transferred to the icu and ecmo was continued for several more days without issue.The patient was hemodynamically compromised for approximately 1 minute at the time of the failure and a further 30 seconds as the console was exchanged.The low flow and low pressure alarms resolved after the speed was increased.

Manufacturer Narrative

Section d10, 3, h4: additional information manufacturer's investigation conclusions: the reported event of the patient¿s centrimag pump atypically stopping was not confirmed; however, the reported event of low flow alarms was confirmed.A log file was extracted from the returned centrimag console and was reviewed.On (b)(6) 2019, the patient¿s flow values were observed to be unsteady within the timeframe of 16:59 ¿ 17:31, ranging between ~4.0 to 0 lpm.An f2: flow signal interrupted alarm was observed at 17:02, and many f3: flow below minimum alarms were observed throughout these events.Flow values became typical throughout the remainder of the log file after the final alarm was cleared at 17:31.The patient¿s centrimag pump was not observed to have shut down atypically throughout the log file and was observed to always operate at speeds close to the set speed when in use by a patient, even during the numerous observed low flow events on (b)(6) 2019.Events with timestamps of the event date, (b)(6) 2019, were not observed within the log file.No other notable events were observed.The returned centrimag console (serial number (b)(6)) was functionally tested on (b)(6) 2020.The console operated for several days and no atypical events occurred throughout all testing.The serviced and tested console was returned to the customer site after passing all tests per procedure.The root cause of the reported event was unable to be conclusively determined through this analysis.Review of the device history record for centrimag console s/n (b)(6) showed the device was manufactured in accordance with manufacturing and qa specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE WITH EM-TEC ADULT FLOW PROBE (VAS/ECMO)
• 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: 9708521
• MDR Text Key: 181786933
• Report Number: 2916596-2020-00792
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 06/17/2020

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 Model Number: 201-90401
• Device Catalogue Number: 201-90401
• Device Lot Number: 6224746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/13/2020
• Supplement Dates Manufacturer Received: 05/29/2020
• Supplement Dates FDA Received: 06/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention