MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG MOTOR, US

Model Number 102956

Device Problems Pumping Stopped (1503); Infusion or Flow Problem (2964)

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

Event Date 06/19/2019

Event Type  Injury  

Manufacturer Narrative

The cause of the event is unknown.The cmag console was also exchanged and is captured under mfr # 2916596-2019-03154.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 (cmag) console alarmed showing no flow and no rpms.The cmag console and motor was successfully exchanged with the backup cmag system.The patient's mean arterial pressure (maps) dropped to 50s but quickly recovered.

Manufacturer Narrative

Section h3,4: additional information.Manufacturer's investigation conclusion: the reported event of the console alarming and no flow and rpm was not confirmed.The centrimag motor (serial #: (b)(6) was returned for analysis; however, no log files were submitted for review.The motor underwent a resistance and insulation test on the motor cable and functioned as intended.The motor was forwarded to the service depot.The returned motor was evaluated and tested under work order #(b)(4).The reported event of the console having no flow or rpms was not able to be verified or duplicated.The motor was run and tested for an extended period of time with the test console and flow probe.There were no alarms present during testing and there were no issues with flow or rpms.The motor functioned as intended.A full functional checkout was performed, and the unit passed all tests.The root cause for the reported event was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG MOTOR, US
• Type of Device: CENTRIMAG MOTOR
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8767743
• MDR Text Key: 150275294
• Report Number: 2916596-2019-03153
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140078
• UDI-Public: 07640135140078
• 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: 09/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102956
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR