MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®, 14V LI-ION BATTERY CLIP SET; VENTRICULAR (ASSIST) BYPASS

Model Number	2865
Medical Device Problem Code	Corroded (1131)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a low voltage alarm occurred on one of the system controller cables.It seemed that both the battery clip and one of the batteries were damaged.There were dark signs on the connections.The battery clip and battery were exchanged.Battery mfr# 2916596-2024-01430.
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
Additional information was received that the alarms resolved after exchanging the battery clip and battery.
Additional Manufacturer Narrative
D1: corrected d4: corrected manufacturer's investigation conclusion: the reported event of low voltage alarms was unable to be confirmed; however, the reported event of damage to the 14v battery clip was able to be confirmed.The 14v battery clip (lot number: 8029720) was returned for analysis.The 14v battery clip was connected to the labs mock loop test equipment.A fully charged test 14v battery was inserted into the battery clip several times without issue.The returned battery clip was run on the lab test equipment without any alarms noted.The clip was able to support the mock loop while connected to both power cables and while the battery and cables were manipulated while connected to the clip.The 14v battery clip supported the labs test equipment without issue.The dark marking on the clip was attempted to be cleaned; however, the marking did not come off.The marking did not affect the functionality of the clip.The clip functioned as intended.The device history records were reviewed for the 14v battery clip (lot number: 8029720) and was found to pass all manufacturing and qa specifications before being shipped to the customer.Heartmate iii instructions for use (rev.G) section 7 entitled ¿alarms and troubleshooting¿ and heartmate iii patient handbook (rev.G) section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including low voltage alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate iii instructions for use (rev.G) section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook (rev.G) section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®, 14V LI-ION BATTERY CLIP SET
• Common Device Name: VENTRICULAR (ASSIST) 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: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18862729
• Report Number: 2916596-2024-01431
• Device Sequence Number: 12832723
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)8029720(11)210719
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: P160054
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Model Number: 2865
• Device Catalogue Number: 2865
• Device Lot Number: 8029720
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 03/07/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 71 KG