MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 1ST GENERATION PRIMARY CONSOLE

Model Number 102954

Device Problem Overheating of Device (1437)

Patient Problem No Patient Involvement (2645)

Event Date 03/21/2019

Event Type  Injury  

Manufacturer Narrative

Approximate age of device: the [motor] is not a single use device.The approximate age of the device is 8 years 2 months.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

It was reported that an unspecified patient was being supported with a ventricular assist device for acute support.It was reported that a call was received.The cmag was reported to start smoking during the battery exchange process.The biomedical engineer returned the unit in for repair.No further information was provided.

Manufacturer Narrative

Section b5, g1, g2: corrected data.Section h3: additional information.Manufacturer¿s investigation conclusion: the report of a centrimag console smoking during battery exchange was confirmed and reproduced during testing of the returned centrimag primary console (serial number (b)(6).The returned console was evaluated and tested by the service depot.Upon arrival an internal inspection of the console was performed.Upon opening the console, a strong burnt smell persisted, confirming the reported event.A nonapproved battery was observed unplugged from the main printed circuit board (pcb).This battery was not reconnected to the main pcb to prevent further damage to the console's electronic components.A lab owned battery was installed in order to further evaluate the unit.Upon powering the console, it was noticed that the flow was not being displayed.This issue was isolated to the installed main pcb.Due to a lack of replacement main pcbs for the 1st gen primary console, the defective component could not be replaced.The customer was notified and responded that they wanted the console returned unrepaired.Applicable sections of the centrimag primary console service process were performed.The console was then scrapped from the customer's product inventory.It was labeled as defective and not suitable for human use.The root cause of the main pcb being damaged was narrowed down to the nonapproved battery installed in the unit.However, it could not be conclusively determined if the battery caused the issue or if it was caused by an improper connection of the battery to the console during battery replacement.The 1st gen centrimag primary console field battery replacement document describes the steps for properly replacing a primary console internal battery.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.

Event Description

Additional information: it was reported this event occurred with no patient involvement.

• Brand Name: CENTRIMAG 1ST GENERATION PRIMARY CONSOLE
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8492934
• MDR Text Key: 141244679
• Report Number: 2916596-2019-01503
• Device Sequence Number: 1
• Product Code: DWA
• 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: 07/31/2019

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
• Device Catalogue Number: 102954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2019
• Initial Date FDA Received: 04/08/2019
• Supplement Dates Manufacturer Received: 07/31/2019
• Supplement Dates FDA Received: 07/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1