MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG 2ND GENERATION PRIMARY CONSOLE; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-90411

Device Problem Use of Device Problem (1670)

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

Event Date 07/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The patient was supported by an extracorporeal circulatory support device on (b)(6) 2018.It was reported a battery maintenance alarm was observed on the centrimag console.The console was exchanged out and battery maintenance was to be performed at the hospital.There was no delay in the procedure or adverse impact to the patient.As of (b)(5) 018, the patient was still supported by an extracorporeal circulatory support device.No additional information was provided.

Manufacturer Narrative

The reported event could not be confirmed because the centrimag primary console was not returned for evaluation.Additionally, a root cause for the event could not conclusively be determined.A review of the device history records, including sterilization and packaging documentation, found no deviations from manufacturing specifications.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA CH-80 05; SZ CH-8005
• MDR Report Key: 7729307
• MDR Text Key: 115361114
• Report Number: 2916596-2018-03042
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140702
• UDI-Public: 07640135140702
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/27/2018
• Supplement Dates Manufacturer Received: 10/31/2018; 02/26/2020
• Supplement Dates FDA Received: 11/15/2018; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 71