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

Model Number	2865
Medical Device Problem Codes	Mechanical Problem (1384); Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2025
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 the patients batteries were getting wet upon showering.The system controller was alarming for low voltage.When the patient looked in their shower bag, the patient noticed the batteries were wet with water at the bottom of the shower bag.The system controller was in the system controller holder and was not wet.The patient connected to mobile power unit (mpu) power and was instructed to use new battery clips and batteries.The old batteries and battery clips were taken out of use.No water damage to the system controller was observed and the system controller passed a self-test.Log file review did not reveal any low voltage events; however, these events may have been overwritten by new incoming data.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of low voltage alarms due to fluid ingress on the 14v li-ion battery clip (lot number: 8715564) was unable to be confirmed.Data was reviewed in the submitted log files, but no atypical alarms were noted in the data reviewed, and the system controller appeared to function as intended for the duration of the data reviewed.The battery clip was not returned for analysis.Provided information indicated that the battery clip got wet while the patient was showering when the gogear shower bag leaked water into the battery compartment.It was reported that the battery clips and 14v li-ion batteries were exchanged, and the reported alarms resolved.The root cause of the reported event was unable to be conclusively determined through this analysis.The device history records were reviewed and showed no deviations from manufacturing or qa specifications.Heartmate 3 patient handbook section 4 ¿ ¿living with the heartmate 3¿ explains that the heartmate 3 system components, such as the system controller, 14v batteries, and mobile power unit must be kept dry at all times and to never swim or take baths.Users are instructed not to shower without a doctor¿s approval, and to never shower without the shower bag.This section also states ¿although the external components of the heartmate 3 left ventricular assist system are moisture-resistant, they are not waterproof.Take care to protect system components from water or moisture, whether indoors showering or outdoors in a heavy rain.If the components have contact with water or moisture, you may receive an electrical shock or the pump may stop¿.Heartmate 3 instructions for use section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms (auditory and visual), including power cable disconnect alarms, and the actions to take if the issue does not resolve.Heartmate 3 instructions for use section 3 ¿ ¿powering the system¿ and heartmate 3 patient handbook section 3 ¿ ¿powering the system¿ addresses how to properly use the 14v battery clip.Heartmate 3 patient handbook section 6 "caring for the equipment" describes how to care for and clean all equipment, including the 14v battery clip.Additionally, section 10 entitled ¿safety checklists¿ instructs users to regularly inspect their accessories ¿ including their battery clips ¿ for damage, and to replace any equipment that appears damaged or worn.The patient handbook and the instructions for use caution the user 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: 22010940
• Report Number: 2916596-2025-02706
• Device Sequence Number: 7837133
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715(10)8715564(11)221214
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: 8715564
• Was Device Available for Evaluation?: No
• 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: 04/15/2025
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 05/13/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/14/2022
• 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: 51 YR
• Patient Sex: Male
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American