MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 11 VOLT LI-ION BACKUP BATTERY; VENTRICULAR (ASSISST) BYPASS

Model Number	106128
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient called because they could not perform a self-test on their system controller and the screen on their system controller turned yellow.The patient's system controller was replaced.It was also reported that the was yellow liquid found in the battery compartment when the backup battery was assessed.The product was returned was evaluation.Related manufacturer's reference number: 2916596-2021-05383.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the heartmate ii system controller, serial (b)(6), was returned for analysis with the backup battery, serial (b)(6)following the reported event of fluid ingress.The returned backup battery was evaluated with the controller under mfr # 2916596-2021-05383.The 11v battery was inspected and accepted into storage location on 22jul2019.The patient handbook cautions the users to call their hospital contacts if they think, for any reason, any portion of their equipment is not functioning as usual, is broken, or they are uncomfortable with the operation of the equipment.Heartmate ii instructions for use section -¿equipment storage and care¿ and heartmate ii patient handbook section -¿caring for the equipment¿ explain how to properly maintain the integrity of the system controller.No further information provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE 11 VOLT LI-ION BACKUP BATTERY
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 12611422
• Report Number: 2916596-2021-05384
• Device Sequence Number: 1348486
• Product Code: DSQ
• UDI-Device Identifier: 00813024011255
• UDI-Public: 00813024011255
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: P060040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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: Lay User/Patient
• Device Expiration Date: 06/11/2021
• Device Model Number: 106128
• Device Catalogue Number: 106128
• Device Lot Number: 7098409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• 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: 09/13/2021
• Supplement Date Received by Manufacturer: 11/23/2021
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2019
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 95 KG