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

Model Number	1440
Medical Device Problem Codes	Failure to Charge (1085); Overheating of Device (1437); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
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 dog had urinated on the universal battery charger (ubc) and the patient reported a burning smell at the time of the event.They presented to the clinic on (b)(6) 2024 with a damaged ubc and issues with a 14v battery.Slot 1 in the ubc was red and the battery that was charged in that slot was damaged.The battery was noted to have been burned.
Additional Manufacturer Narrative
Section d1 - brand name: corrected.Section d4 - catalog number: corrected.Section d4 - primary unique device identification (udi) number: corrected.Manufacturer's investigation conclusion: the reported event of a damaged universal battery charger (ubc) and an issue with slot 1 was confirmed via evaluation.The heartmate universal battery charger (serial number (b)(6)) was evaluated at the service depot.The ubc was disassembled, and fluid ingress damage was observed on the main printed circuit board (pcb) and the pocket cable charger for slot 1.The patient was given a replacement battery charger, and the damaged unit was forwarded to product performance engineering (ppe) for further analysis.Visual inspection of the forwarded ubc revealed fluid ingress on the metal charging contacts of slot 1.The ubc was disassembled, and it was observed that the fluid ingress on the main pcb caused electrical damage on multiple components associated with slot 1, voltage sense, and logic channels.The ubc was not powered on due to the extent of the damage.The root cause for the reported event was communicated to be the patient¿s dog urinating on the battery charger.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.The heartmate 3 patient handbook section 3 entitled ¿powering the system¿ and the heartmate 3 instructions for use (ifu) section 3 entitled ¿powering the system¿ instruct the user to keep the universal battery charger away from liquid at all times.Fluid ingress within the battery charger may cause issues in operations or may cause an electric shock.The heartmate universal battery charger ifu sections entitled ¿warnings and cautions¿ and 6.0 ¿routine inspection and cleaning¿ instructs users to never allow liquid to enter the interior of devices, and to keep the ubc away from liquid as much as possible.The heartmate 3 patient handbook section entitled "emergency contact list" cautions 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®
• 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: 19305948
• Report Number: 2916596-2024-02643
• Device Sequence Number: 7243932
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: (01)00813024010678(11)240313
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 09/11/2024

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
• Date Returned to Manufacturer: 05/03/2024
• 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: 04/25/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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: 32 YR
• Patient Sex: Male
• Patient Weight: 136 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White