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

Model Number 201-10002

Device Problems Vibration (1674); Infusion or Flow Problem (2964)

Patient Problem No Patient Involvement (2645)

Event Date 09/07/2019

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the centrimag motor was vibrating, a flow sensor fault occurred, the console display blanked then returned, and there was reduced flow from the system.The account exchanged to the backup system to which normal support resumed.No further information was provided.

Manufacturer Narrative

Section d3, g1, and g2: correction.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a flow sensor fault with a blank flow reading was confirmed via the log file and the investigation.A log file was extracted from the returned centrimag console (serial number (b)(6), evaluated under mfr # (b)(4).Per the log file, on (b)(6) 2019, the console was supporting the system at a speed of ~3800 rpm and ~2.85 lpm.An active s3 alarm was observed to have been caused by a ¿sf_ifd_shutdown_detected¿ sub-fault on (b)(6) 2019 at 9:14.A flow supply sub-fault was also observed within the same minute as a result of this event.After this event, speed dropped to ~3400 rpm and flow reading would have been blank with "--.--" on the console display, consistent with the reported information.The system was observed to be manually shut down at 11:19 on the same day and was not in use by the patient throughout the remainder of the log file.No other notable events were observed.The returned centrimag motor (serial number (b)(6) was tested on (b)(6) 2020.The motor was tested alongside the customer¿s returned console and flow probe, as well as a test flow probe.An s3 fault alarm occurred when either probe was in use during testing.Reports of similar events have been documented and corrective action (capa) has been initiated to investigate the issue.The motor was determined to be the root cause of the reported event of a blank flow reading with a flow sensor fault (correlating to an s3 alarm) and was sent to zurich for recalibration.Final disposition of the motors will be determined by the capa.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, OUS
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 9261112
• MDR Text Key: 164465835
• Report Number: 2916596-2019-05141
• 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: foreign
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/09/2021

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: 201-10002
• Device Catalogue Number: 201-10002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/14/2019
• Initial Date FDA Received: 10/31/2019
• Supplement Dates Manufacturer Received: 02/10/2020; 04/07/2020; 06/09/2021
• Supplement Dates FDA Received: 02/28/2020; 04/24/2020; 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: FA-Q319-MCS-1
• Patient Sequence Number: 1