MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH THORATEC RECHARGEABLE LI-ION BATTERY; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 201-50207

Device Problem Nonstandard Device (1420)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2021

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 during installation of new centrimag system it was found that there were two backup batteries that already expired back in (b)(6) 2020.The batteries were exchanged.The first battery product was referenced in manufacturer report number# 3003306248-2021-04047.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the centrimag battery being expired out of box was confirmed, as the returned centrimag battery (serial number (b)(6)) was observed to have expired on 30nov2020 upon arrival.The returned battery was connected within a known working test centrimag console and was tested alongside known working test centrimag equipment.When ac power was disconnected from the console, the battery operated the system as intended for an extended period despite the battery having been expired.Battery maintenance was also performed with the returned battery, and the battery passed.Atypical events were unable to be reproduced throughout all testing.A corrective action is being requested in order to address the issue of the battery being expired out of box.Review of the device history record for centrimag battery, serial number (b)(6), showed the device was manufactured in accordance with manufacturing and qa specifications.Review of the device history record for centrimag console that the battery was placed in (serial number (b)(6)) also showed device was manufactured in accordance with manufacturing and qa specifications.The centrimag operating manual ¿2nd generation centrimag primary console maintenance schedule¿ instructs users that the centrimag¿s internal battery must be replaced every two years.However, the user may not replace the battery without proper training.Users are instructed to request assistance by contacting abbott if the internal battery requires replacement.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

Additional information to the manufacturer's investigation conclusion: a manufacturing analysis task was opened in order to further investigate the issue of the battery being expired out-of-box, and the centrimag manufacturing procedure was updated as a result; however, the root cause of the reported event was unable to be conclusively determined.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: THORATEC RECHARGEABLE LI-ION BATTERY
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12625829
• MDR Text Key: 278409735
• Report Number: 3003306248-2021-04048
• Device Sequence Number: 1
• Product Code: DWA
• UDI-Device Identifier: 07640135140535
• UDI-Public: 07640135140535
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/05/2022

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 Expiration Date: 07/26/2018
• Device Model Number: 201-50207
• Device Catalogue Number: 201-50207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/23/2021
• Initial Date FDA Received: 10/13/2021
• Supplement Dates Manufacturer Received: 02/28/2022; 11/28/2022
• Supplement Dates FDA Received: 02/28/2022; 12/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1