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

Model Number L201-90411

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2020

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

It was reported that the centrimag console alarmed battery module fail twice and the alarm hasn't repeated.The doctor was at the bedside when this happened and elected not to change the console.It was reported it was advised to keep a backup available and not transport the patient without being informed.The battery indicator shows 3.45h and the console has been plugged in the entire time.The rpms were 3800 with 4.5 l/min flow.No adverse event reported, and no additional information reported.

Manufacturer Narrative

No further information was provided.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a battery module fail was not confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis and a log file was downloaded from the console for review.A review of the downloaded log file showed events spanning approximately 115 days ((b)(6) 2016 per time stamp).The reported event date of (b)(6) 2020 was not captured in the log file, nor was the reported event of a battery module fail alarm.The console was evaluated and tested under work order: (b)(4).The reported event of a battery module fail was not duplicated or verified.The console was run for an extended period of time with the returned and associated flow probe and a test motor.The console did not alarm at any point and no issues with the battery were noted.A full functional checkout was performed, and the unit passed all tests.The console was returned to the rental pool.The root cause for the reported battery module fail alarm was not conclusively determined through this analysis.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG 2ND GENERATION PRIMARY CONSOLE RENT
• 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: 9690001
• MDR Text Key: 179792282
• Report Number: 2916596-2020-00525
• 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: 04/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: L201-90411
• Device Catalogue Number: 201-90411
• Device Lot Number: IFS103676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 90