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

Model Number	HMT1100
Medical Device Problem Codes	Communication or Transmission Problem (2896); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
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 had degree of recovery.Flows sometimes dipped to less than 2.5 liters per minute (lpm) because of this.Controller was exchanged to 2.0 lpm software.Couldn't use the low flow alarm threshold as it was not working.The app crashed every time the bluetooth adapter was connected from the list.A new 2.0 lpm system controller was used from the shelf.
Additional Manufacturer Narrative
Section d4 (primary unique device identification (udi) number): correction; there was no heartmate touch involved in this event; therefore, 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.Section d5: correction section d9: correction section h5: correction section h6 (medical device problem code): correction section h8: correction manufacturer's investigation conclusion: it was reported that the low flow alarm threshold (lfat) tool was not working when attempting to adjust the lfat to 2.0 liters per minute (lpm).The lfat tool reportedly crashed repeatedly when attempting to connect to the wireless adapter.A new system controller with a lfat of 2.0 lpm was used instead.The reported event is related to the lfat tool and could not be correlated to an issue with the heartmate touch.The lfat tool is a tool used by abbott representatives to adjust the lfat and is not a commercially available product.Heartmate 3 patient handbook (rev.G), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.A), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the power cable disconnect and low voltage advisory alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate 3 patient handbook (rev.G) 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 TOUCH¿
• 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: 20982492
• Report Number: 2916596-2024-52451
• Device Sequence Number: 18391071
• Product Code: DSQ
• UDI-Device Identifier: 05415067032058
• UDI-Public: (01)05415067032058
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2025

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: Health Professional
• Device Model Number: HMT1100
• Device Catalogue Number: HMT1100
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 03/26/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 03/28/2025
• 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 Sex: Unknown