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

Model Number	2865
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: device serial number and lot number were not provided, and expiration date and manufacture date (h4) cannot be determined.The primary udi number in d4 is reflective of all available information.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 an urgent log file reading was requested for a patient whose consolidated bag with the batteries they were connected to fell in water for a few seconds.There was a power cable disconnect on the white power cable for 30 seconds that resolved when the battery and clip were pulled out of water.A few controller self-tests were done, and no issues were noted.The overall history of the log file was just over 3 hours due to frequent pulsatility index (pi) events filling up the data bank of the log file.The data on (b)(6)2024 was unavailable.However, it was recommended to exchange the equipment that was submerged due to the potential for corrosion over time from the moisture ingress.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of fluid ingress and atypical power cable disconnect alarms while connected to batteries was not confirmed.A review of the submitted controller event log file spanned approximately 3 hours (on (b)(6) 2024 from 11:36:11 ¿ 14:43:09 per time stamp).There were only routine power cable disconnect alarms in the log file.The events from 22sep2024 were overwritten by pi events.There were no notable alarms active in the log file.A review of the submitted controller periodic log file spanned approximately 12 days at 1-hour intervals (on (b)(6) 2024 per time stamp).There were no notable alarms active in the log file.The 14v battery clip was not returned for analysis.There were no issues since the incident.There were photos submitted for review.Multiple attempts were made to obtain additional information from the customer regarding the event; however, no response was received.A root cause for the reported event was not conclusively determined through this analysis.Device history records could not be reviewed due to the lot number of the battery clip being unavailable.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 3 instructions for use section 7-¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot power cable disconnect alarms.Heartmate 3 patient handbook section 4-¿living with the heartmate 3¿ states that ¿the heartmate 3 system components must be kept dry.Never expose the system controller, batteries, mobile power unit or power base unit to water.If these system components get wet, your pump may stop.Never take tub baths or go swimming while implanted with the pump.The heartmate® gogear® shower bag must be used while showering to keep the system controller and batteries dry.¿ the ifu states under the weekly safety checklist to clean the metal battery terminals and contacts inside the battery clips and to check for damage.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: 20441416
• Report Number: 2916596-2024-06627
• Device Sequence Number: 8090605
• Product Code: DSQ
• UDI-Device Identifier: 00813024010715
• UDI-Public: (01)00813024010715
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 11/25/2024

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
• 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: 09/23/2024
• Supplement Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 11/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White