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

Model Number 201-90411

Device Problem Failure to Pump (1502)

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

Event Date 04/29/2019

Event Type  Injury  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for investigation.The evaluation is not yet complete.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that a centrimag gen 2 that was supporting a patient had a s3 alarm.The entire pump was exchanged.No further information provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event was confirmed through the analysis of a data log file retrieved from the returned centrimag 2nd gen primary console associated with this event.Per the log file, on (b)(6) 2018 the console was supporting a system at the set speed without any issues for over 31 hours.At approximately 7:16am on (b)(6) 2019 pump speed was set to 3900rpm and the system responded as designed.During this time flow was measured at ~2.7lpm.Between approximately 7:20am and 7:28am the console alarmed with multiple system alert:s3 alarms due to active sf_ifd_supply_voltage faults.These alarms activated and cleared 5 separate times during this time frame.Once the final alarm cleared at 7:28am no further issues were observed.These alarms did not affect the console's ability to support the pump at the set speed and flow remained stable throughout the log file.The console continued to support the system without any further issues until it was powered down at approximately 8:35am of the same day.The returned centrimag 2nd gen primary console and motor (reported under mfr #2916596-2019-02212) were evaluated and tested at mcs zurich.Testing of the motor's cable revealed that insulation values varied slightly when the cable was bent, but they did not go out of range.However, since the motor failed testing at mcs burlington and exceeded its lifetime of 5 years (mfg.2011), a decision was made to scrap the motor.Although testing of the motor indicated that there were early stages of conductor breakdown in the cable, it didn't appear to be severe enough to be conclusively correlated to the reported event.The returned console was tested with its associated flow probe (sn (b)(6)), test motor, and mock circulatory loop.The system was operated for 2 days at the operating parameters captured at the time of the reported event, and it always operated as intended.As a result, the root cause of the reported event could not be conclusively determined.However, the most likely cause of the issue was determined to be the motor or a failure of the sps printed circuit board (pcb).Since the defective motor was scrapped, the sps pcb was replaced as a preventative measure.After the board replacement, the unit was reprocessed according to the repair and maintenance procedure with the returned flow probe and both devices passed all tests.The tested console and flow probe were sent back to mcs burlington for final processing and disposition.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 CA CH-80 05; SZ CH-8005
• MDR Report Key: 8620327
• MDR Text Key: 145390739
• Report Number: 2916596-2019-02211
• 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
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention