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

Model Number 201-90411

Device Problem Electrical Power Problem (2925)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2019

Event Type  malfunction  

Manufacturer Narrative

Patient weight not provided.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.

Event Description

The site reported the centrimag console displayed a b4 battery alarm.The patient was switched to a back-up console.The site attempted to run the battery re-conditioning on 2 console without success.No further information was reported.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a b4 alarm and failed battery maintenance was confirmed.The centrimag 2nd generation primary console (serial #: (b)(6)) was returned for analysis to the service depot and was evaluated and tested under work order #54181047.The reported event was able to be duplicated and verified.The battery underwent battery maintenance twice and failed.The battery pack was replaced and then was able to successfully complete battery maintenance.The console was connected to a test motor and flow probe and functioned as intended.A full functional checkout was performed and passed all tests.The console was returned to the customer site.The battery was forwarded to ppe for analysis.The battery was returned to ppe and was connected to a test console for battery maintenance.The battery did not pass battery maintenance.The battery was further investigated, and no issues were observed.The pcb is potted and not able to be accessed.No further troubleshooting was able to be performed.A log file was downloaded from the returned console for review.A review of the downloaded log file showed events spanning approximately 36 days (b)(6) 2019 ¿ (b)(6) 2020 per time stamp).The reported event date of 10dec2019 was not captured in the log file.A b4, battery maintenance required, alarm was active once received at abbott on 20jan2020 at 09:58.The root cause for the reported event was conclusively determined to be due to a damaged battery pcb.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Section d3 and g2: corrected data.

• 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: 9541964
• MDR Text Key: 179424301
• Report Number: 2916596-2019-06119
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K131179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/19/2020

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: 201-90411
• Device Catalogue Number: 201-90411
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/02/2020
• Supplement Dates Manufacturer Received: 02/10/2020; 02/28/2020; 03/18/2020
• Supplement Dates FDA Received: 02/27/2020; 02/28/2020; 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 14 YR