MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE®; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Codes	Overheating of Device (1437); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Section d4: 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 patient was plugging in their universal battery charger (ubc) into their camper and later on heard a pop and what smelled like smoke coming from the ubc.The ubc then alarmed and turned off.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the universal battery charger (ubc) no longer functioning as intended was confirmed via analysis of the returned ubc.The returned ubc was evaluated by service depot and during testing the returned ubc was powered on and the unit booted up; however, upon powering on the unit, a red light illuminated on channels 2 and 3.The unit was then disassembled to inspect the internal components revealing that multiple components in channels 2 and 3 of the main printed circuit board (pcb) had become damaged; this would result in the red light illuminating on channels 2 and 3.A black residue was also observed surrounding the damaged components; this is consistent with the reported event of a smoke like smell coming from the ubc.Due to the observed damage to the pcb, no further testing was performed, and no repairs were performed.It was noted that the customer no longer wanted the unit back and it was agreed to scrap the damaged unit.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate ubc instructions for use (rev.B) provides an overview of how to use and care for the ubc.Section 5 ¿monitoring performance¿ covers all faults, including charger pocket faults, and the actions to take when a fault occurs.Heartmate 3 instructions for use (rev.C) section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook (rev.D) section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms, including faults that occur on the ubc, and the actions to take if the faults do no resolve.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.The device history records were reviewed, and the records revealed that the universal battery charger (ubc), serial number (b)(6), was manufactured in accordance with manufacturing and qa specifications.The ubc was shipped to the customer on 09sep2010.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE®
• 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: 19766726
• Report Number: 2916596-2024-04711
• Device Sequence Number: 8541555
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(11)100831
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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: 1440
• Device Catalogue Number: 1440
• 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: 07/03/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2010
• 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: 70 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White