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

Model Number 201-90411

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/23/2019

Event Type  Injury  

Manufacturer Narrative

The patient's initials or identifier were not provided.The patient's date of birth and age were not provided.The patient¿s gender was not provided.The patient¿s weight was not provided.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 by the centrimag console which was running a centrimag pump.It was reported that the cmag console failed with a p3 alarm reading on the console screen, which then defaulted the rpms to around 3300 giving it 3l of flow according to the hospital staff.The motor and console were change; however, this is the second motor and console to malfunction on the same patient on the same day.No additional information was provided.

Manufacturer Narrative

Section patient identifier, age or date of birth, sex, and weight: additional information.Description of event or problem: in the initial submission it was reported that this is the second motor and console to malfunction on the same patient in the same day.The first motor and console are reported under mfr #'s 2916596-2019-03234 and 2916596-2019-03185, respectively.Mfr name, city & state, mfr site, and report source: correction.The motor in use during this event was reported under mfr # 2916596-2019-03393.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of a drop in pump speed was confirmed through the analysis of the returned centrimag 2nd gen primary console associated with this event.Per the log file's timestamp, on (b)(6) 2019 the console was supporting a system at a speed of ~4800rpm and a flow of ~5.2lpm for over 6 hours.At approximately 10:14pm of the same day the console alarmed with an active system alert:s3 alarm as a result of an active sf_ifd_shutdown_detected fault.Soon after, pump speed dropped down to ~3200rpm and the flow reading became blank with a reading of 0lpm.As a result, the console alarmed with set speed not reached: m5 and flow signal interrupted:f2 alerts.However, the motor continued to support the pump and flow would have continued to be present.Attempts to adjusted pump speed were unsuccessful.These alerts were captured until the pump was disconnected and the console was powered down at approximately 10:27pm.The log file did not capture any p3 alarms, as a result, the report of such an alarm could not be confirmed.The returned centrimag 2nd gen primary console was evaluated and tested by the service depot.The reported complaint could not be verified nor duplicated during their evaluation.The console was tested along with its associated motor and flow probe returned under this complaint as well as with a test motor.The system was operated for an extended period of time and no issues were observed.No alarms nor flow probe problems were detected.During testing it was noted that the console's battery was expiring soon on august 31, 2019.The expiring battery was replaced with a new one free of charge and battery maintenance was performed successfully.Full functional checkout was performed per the centrimag 2nd gen primary console service process 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.Although the root cause of the reported event could not be conclusively determined, reports of similar events have been documented and corrective action (capa) has been initiated to investigate the issue.This investigation determined that the root cause of the events captured in the log file was related to the motor used during the event.Action is being taken to address the issue and 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: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 8811878
• MDR Text Key: 151735833
• Report Number: 2916596-2019-03394
• 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,Followup
• Report Date: 12/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 35 YR
• Patient Weight: 88