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

Model Number 201-30300

Device Problem Overheating of Device (1437)

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

Event Date 07/01/2019

Event Type  Injury  

Manufacturer Narrative

This event occurred at (b)(6).The motor is reported under mfr# 2916596-2019-03256.The device is expected to return.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that during an ecmo procedure with the centrimag pump, there were a couple of alarms and the value of the flow disappeared even when the pump was running and the blood flow was clearly present.There were motor too hot, speed not reached, system, and low flow alarms.The motor started to make noise and the motor and console were switched out.Patient had no issues or adverse symptoms during the event.No further information was provided.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event of multiple alarms, a blank flow value, and a grinding motor noise was not confirmed.The returned centrimag 2nd gen.Primary console (serial number (b)(6)) was tested at mcs zurich.A log file was extracted from the console upon arrival.The reported event was not confirmed within the extracted log file, as the log file¿s first entry date was (b)(6) 2019.The event date was recorded as (b)(6) 2019.None of the reported events were reproduced during functional testing.The console, alongside a test centrimag motor, operated a pump for 2 days at 3000 rpm and 5.5 lpm without triggering any faults.The investigation was determined to have been inconclusive, as no faults were reproduced and the event date was unable to be analyzed within the log file.The tested console was returned to edc belgium.The root cause of the reported event was unable to be determined through this analysis.No further information was provided.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 CH-80 05; SZ CH-8005
• MDR Report Key: 8795024
• MDR Text Key: 151188536
• Report Number: 2916596-2019-03254
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30300
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/16/2019
• Supplement Dates Manufacturer Received: 11/20/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention