MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE® SEALED LEAD ACID BATTERY; VENTRICULAR (ASSIST) BYPASS

Model Number	109200
Medical Device Problem Codes	Use of Device Problem (1670); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the new power module battery was not working.The battery was disconnected for 10+ minutes and reconnected, a system test was attempted, however the red battery and yellow wrench alarms still showed.The power module backup battery was exchanged.It was additionally reported that the patient's spouse exchanged their system controller due to an alarm.It was unclear what the alarm was as they immediately panicked and switched out the system controller without calling the clinic.The patient's spouse was unable to fully connect the driveline to the backup system controller as they could not get it to lock.The patient became unresponsive and went into cardiac arrest due to the pump being off due to the driveline being unable to be reconnected to the system controller.It was noted that over the phone the clinic was able to walk the spouse through the steps to resolve the issue.Upon arrival to the emergency department, it was reading "replace system monitor" and it was exchanged.Through further investigation it was found that the patient was still on their original system controller.It was assumed that the alarm at home may have been a replace system controller alarm.Log files were submitted for review and captured a controller internal fault event on (b)(6) 2024 at 23:25:57.The driveline was disconnected at 23:29:32 and reconnected at 23:39:39 with the pump returning to set speed.The pump operated at set speed until (b)(6) 2024 at 1:12:59 when the driveline was disconnected.It was noted on 27june2024 that the patient was doing well now and was discharged home with no notable deficits/issues.Related manufacturer reference number: (b)(4) (pump) related manufacturer reference number: (b)(4) (primary system controller) related manufacturer reference number: (b)(4) (system controller attempted to be connected).
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 once the manufacturer¿s investigation is complete.
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 additionally reported that the serial number of the power module was unknown as the clinic had received 5 new power modules and it was unknown which power module the patient was connected to.It was noted that all of the power modules now had working batteries.
Additional Manufacturer Narrative
Section d: product information corrected.The power module backup battery malfunction was determined to be unrelated to this event and was not involved with this patient.The reported event of the power module battery not working, and investigation will be captured under mfr # 2916596-2024-06605.

• Brand Name: HEARTMATE® SEALED LEAD ACID BATTERY
• 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: 19755671
• Report Number: 2916596-2024-04326
• Device Sequence Number: 8875022
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)260131
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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,Followup
• Report Date (Section B): 10/15/2024

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: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GX047
• 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: 06/25/2024
• Supplement Date Received by Manufacturer: 08/16/2024; 09/26/2024
• Initial Report FDA Received Date: 07/16/2024
• Supplement Report FDA Received Date: 09/02/2024; 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 76 KG