MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Code	Overheating of Device (1437)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2023
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 complete.
Event or Problem Description
It was reported that the patient's universal battery charger (ubc) was emitting smoke.A replacement for the ubc was requested.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of smoke emitting from the ubc was to be confirmed.The universal battery charger (ubc) (serial number: (b)(6) was returned for analysis and was evaluated and tested.The ubc was powered on and smoke began to emit from the unit in addition to alarms.The ubc was opened, and several components on the logic printed circuit board (pcb) were severely damaged in addition to evidence of fluid ingress.A purchase order request was sent to the customer; however, after several attempts, the customer did not respond.The ubc will be returned to the customer unrepaired and labeled ¿not for human use.¿ the root cause of the reported event was unable to be conclusively determined through this investigation; however, fluid ingress may have contributed to the reported event.The device history records were reviewed for the ubc (serial number: (b)(6) and was found to pass all manufacturing and qa specifications before being shipped to the customer.The heartmate universal battery charger instructions for use (ifu) instructs users to not use a damaged ubc, and to obtain a replacement if necessary.Section 6.0 routine inspection and cleaning within the ifu instructs users to check the ubc for damage at least once per week.Heartmate iii instructions for use section 8 entitled ¿equipment storage and care¿ and heartmate iii patient handbook section 6 entitled ¿caring for the equipment¿ addresses how to properly care for and maintain the equipment for proper use including how to ensure that the controllers and equipment do not get wet.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 UNIVERSAL BATTERY CHARGER
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17606002
• Report Number: 2916596-2023-06295
• Device Sequence Number: 6125416
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2023

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
• 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: 08/18/2023
• Supplement Date Received by Manufacturer: 11/21/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 11/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/30/2022
• 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: 35 YR
• Patient Sex: Female
• Patient Weight: 72 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White