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

Model Number 201-90411

Device Problems Decreased Pump Speed (1500); Use of Device Problem (1670)

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

Event Date 02/25/2019

Event Type  Injury  

Manufacturer Narrative

Patient age was not provided.Patient weight was not provided.Approximate age of device - can not be determined.The patient remains ongoing with the device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

The patient was implanted with a left ventricular assist device (lvad).The date of implant is not known.It was reported the patient was being supported by centrimag and the nursing staff noticed a dash dash dash on the flow and the speed automatically reduced from 4200 rpms to 3000 rpms to 2000 rpms to 1000 rpms.Perfusion was called & the console & motor was changed to the backup.Patient was back supported without incident.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a drop in flow and speed was confirmed.The centrimag 2nd generation primary console (serial #: (b)(4) was returned to the service depot for analysis.The returned centrimag 2nd generation primary console was evaluated and tested.The service depot was unable to confirm or duplicate the reported drop in flow and speed.The centrimag 2nd generation primary console was tested for an extended period at rpm levels as noted in the complaint with the associated motor (serial #: (b)(4) and flow probe (serial #: (b)(4).No issues with the flow levels were observed.A full functional checkout was performed, and the unit passed all tests.It was noted that the console¿s battery (serial #: (b)(4) will be expiring on 31jul19.The customer was informed and accepted the replacement of the battery.The battery was replaced with a new one and a successful battery maintenance was performed.A new backup system warning label was applied per field action ¿fa-q318-mcs-1¿.A log file was extracted from the system for analysis.A review of the log file showed data spanning approximately 33 days (20feb19 ¿ 25mar19 per time stamp).On 20feb19 at 23:38, the sub fault ¿sf_ifd_shutdown_detected¿ occurred and triggered the ¿system alert: s3¿.The flow dropped to 0 lpm and the motor speed decreased to ~3100 rpm.At the same time stamp, the sub fault ¿sf_ifd_underspeed¿ occurred and triggered the ¿set pump speed not reached: m5¿ alarm and the motor speed decreased to ~2900 rpm.On 20feb19 at 23:39, the sub fault ¿sf_flow_low_amplitude¿ occurred and triggered the ¿flow signal interrupted: f2¿ alarm.At the same time stamp, the ¿motor disconnected: m2¿ alarm occurred and cleared the ¿set pump speed not reached: m5¿ alarm.The ¿system alert: s3¿ alarm also was cleared.The root cause for the reported drop in flow and speed was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3: correction.

• 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: 8420090
• MDR Text Key: 138771772
• Report Number: 2916596-2019-01206
• 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,Followup,Followup
• Report Date: 03/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2019
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: 6073461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Weight: 125