MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 102954

Device Problems Overheating of Device (1437); Noise, Audible (3273)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2019

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 nurse heard a loud humming sound from the patient's centrimag motor.There were no alarms and the device flow was unchanged.The humming resolved after 10 minutes.The nurse reported the motor felt warm but not hot.The patient had been on bivad support for over 30 days.The motor in question was the motor for the lvad.Both the console and the motor were exchanged.No further information was provided.

Manufacturer Narrative

Device manufacture date: additional information.Manufacturer's investigation conclusion: the reported event of a loud humming noise coming from the motor was not confirmed.The centrimag 1st generation primary console (serial #: (b)(4) was not returned for analysis.Provided information indicated that there were no alarms present during the reported event and the flow from the device was unchanged.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 1ST GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 9202001
• MDR Text Key: 163004240
• Report Number: 2916596-2019-04828
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 7640135140672
• UDI-Public: (01)7640135140672
• Combination Product (y/n): N
• PMA/PMN Number: K093832
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/20/2019

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: 102954
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/29/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 12/18/2019
• Supplement Dates FDA Received: 12/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention