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

Model Number	201-50207
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem 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.
Additional 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.
Additional 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
• Common Device Name: 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
• Report Number: 3003306248-2021-04048
• Device Sequence Number: 17238330
• Product Code: DWA
• UDI-Device Identifier: 07640135140535
• UDI-Public: 07640135140535
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2021
• Supplement Date Received by Manufacturer: 02/28/2022; 11/28/2022
• Initial Report FDA Received Date: 10/13/2021
• Supplement Report FDA Received Date: 02/28/2022; 12/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown