MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT AC POWER CORD; VENTRICULAR (ASSIST) BYPASS

Model Number	107760
Medical Device Problem Code	Device Difficult to Setup or Prepare (1487)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2025
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 when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that the patient stated their mobile power unit (mpu) power cable never latched properly.The team replaced the mpu power cable and verified the locking mechanism worked appropriately.There were no alarms.
Additional Manufacturer Narrative
No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
Event or Problem Description
It was reported that there were no log files available.The mpu had a yellow clip, which they thought may have been the v-lock connector on the ac power cord.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of an alternating current (ac) power cable not latching properly was confirmed via evaluation of the heartmate mobile power unit (mpu) ac power cord (lot number 10814683).Visual inspection of the ac power cord revealed the position of the v-lock feature was misaligned.The ac power cord was connected to a test mpu; however, the v-lock feature did not engage.Due to the ac power cord not properly latching to the mpu, the cord was able to be removed without pressing the yellow locking button down.Despite the unsecured connection, the ac power cord was able to supply power the test mpu as intended.Provided information stated that no log files were available and the patient¿s mpu was serial number (b)(6).The root cause for the reported event was determined to be due to the mpu ac power cord v-lock connector being misaligned.A corrective action was initiated to investigate this issue.The heartmate mobile power unit alternating current power cord lot number 10814683 was packaged and shipped with heartmate mobile power unit serial number (b)(6) to (b)(6) medical center.Customer order, (b)(6), was shipped on 23may2025.Device history records were reviewed for heartmate mobile power unit serial number (b)(6) and showed no deviations from manufacturing or quality assurance (qa) specifications.The current revision of the instructions for use (ifu) can be found on the eifu page of the abbott website.Heartmate 3 instructions for use (rev.D) section 3, ¿powering the system¿ and heartmate 3 patient handbook (rev.A) section 3, ¿powering the system¿ explains how to properly use the mobile power unit (mpu).Heartmate 3 instructions for use (rev.D) section f, ¿safety checklists¿ and heartmate 3 patient handbook (rev.A) section 10 ¿safety checklists¿ provide the user with checklists to assist the patient in performing routine maintenance of all components of the heartmate 3 left ventricular assist device, including the mpu.The patient handbook (rev.A) 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 MOBILE POWER UNIT AC POWER CORD
• 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: 22713158
• Report Number: 2916596-2025-05123
• Device Sequence Number: 9611781
• Product Code: DSQ
• UDI-Device Identifier: 05415067038258
• UDI-Public: (01)05415067038258(10)10814683(11)250421
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2025

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: Lay User/Patient
• Device Model Number: 107760
• Device Catalogue Number: 107760
• Device Lot Number: 10814683
• 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: 07/25/2025
• Supplement Date Received by Manufacturer: 09/09/2025; 10/30/2025
• Initial Report FDA Received Date: 08/05/2025
• Supplement Report FDA Received Date: 09/12/2025; 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/21/2025
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: FA-Q225-HF-1
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 115 KG
• Patient Ethnicity: Hispanic