MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102956

Device Problems No Display/Image (1183); Nonstandard Device (1420); Failure to Read Input Signal (1581); Communication or Transmission Problem (2896)

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

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

This event was reported under the console in mfr # 2916596-2019-01690.The complaint investigation determined the reported difficulty was the result of a design related issue.After review of this event and similar incidents, abbott has decided to initiate a voluntary field action for centrimag.Abbott performed a comprehensive investigation which included device analysis, manufacturing evaluation and trend analysis.

Event Description

The patient was being supported with a ventricular assist device for acute support.It was reported that the console went blank during use.During this time, the centrimag unit would not respond to buttons being pressed.The patient was switched to different centrimag units without harm.Loaner units were requested.

Manufacturer Narrative

Serial number was not provided therefore udi not available.Evaluation codes: correction.Manufacturer's investigation conclusion: the complaint was reviewed for hhe 2019-036 and an analysis with regard to capa 120791 was requested.The reported event of the console going blank was confirmed via the log file analysis.The centrimag motor was not returned for analysis; however, a log file was downloaded from the retuned and associated centrimag 2nd generation primary console.A review of the log file showed events spanning approximately 29 days ((b)(6) 2019 per time stamp).The console was running a motor at ~4300 rpm with a flow ~4.2 lpm.On (b)(6) 2019 at 08:10, the sub fault ¿sf_ifd_shutdown_detected¿ activated and triggered ¿system alert: s3¿ and ¿set pump speed not reached: m5¿ alarms.The flow dropped to 0 lpm and the speed dropped to ~3300 rpm.The sub fault ¿sf_flow_low_amplitude¿ was also active which triggered the alarm ¿flow signal interrupted: f2¿.The alarms were able to be muted and cleared.Reports of similar events have been documented and corrective action had been initiated to investigate the issue.The investigation has determined that this event was caused by a motor related issue.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 MOTOR, US
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8944697
• MDR Text Key: 155962493
• Report Number: 2916596-2019-04209
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Device Catalogue Number: 102956
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1