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

Model Number 201-30100

Device Problem Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/16/2018

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for analysis.It has not yet been received.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The patient was placed on extracorporeal circulatory support.The following event was reported: "at 11.30 urgent call.Machine connected to the network in (b)(6), at 11:40 machine prepared charge level 10/10 deconnected from network, at 11.45 ecmo started with battery charged 10/10, at 11:50 motor block with display turned on 'battery below minimum level'¿ the device was reportedly working.No further information was provided.A final report will be submitted when the manufacturer¿s investigation is completed.

Manufacturer Narrative

Sections d10, h3, h4, h8: additional information.Investigation conclusion: the reported events of a motor block and a ¿battery below minimum level¿ alert were not confirmed.The centrimag primary console (serial number (b)(4)) was not returned for analysis, and no pictures or log files were associated with the reported event.The root cause of the reported events was unable to be determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG PRIMARY CONSOLE 1ST GEN
• Type of Device: PRIMARY CONSOLE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• MDR Report Key: 8162677
• MDR Text Key: 130478089
• Report Number: 2916596-2018-05637
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-30100
• Device Catalogue Number: 201-30100
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1