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

Model Number	109200
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4: there was no patient involved in this event.The pma# provided is associated with most recent approval.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 ventricular assist device (vad) coordinator tried to insert the power module backup battery with the serial number (b)(6) into the power module and was confronted with yellow wrench and red hazard symbol alarms.When the backup battery was disconnected and reseated the alarms persisted.
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
The alarms resolved when the ebb was replaced with a new ebb.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a backup battery fault alarm (yellow wrench + red battery symbols) was confirmed, as the alarm was reproduced upon connecting the returned power module backup battery (serial number (b)(6)) to a known working test power module.The returned battery was observed to be damaged near its metal contacts which prevented a battery clip from properly connecting to the battery, even when the clip was securely held.When ac power was disconnected, the battery was able to operate the mock loop as intended despite the alarm and despite the improper connection.Available information indicates that the customer used a new battery to resolve the issue.The observed battery damage could have caused the backup battery fault alarm to occur, as the damage prevented a battery clip from properly connecting to the battery.However, the root cause of the damage was unable to be conclusively determined through this analysis.The 12-volt sealed lead acid battery was observed to pass all initial manufacturing testing per the greatbatch manufacturing datasheet.The heartmate power module instructions for use (ifu) (rev.B, section 2.1 ¿connecting the internal backup battery¿) instructs users on how to properly connect the backup battery to the power module.The battery clip should ¿snap¿ into place on the battery.The heartmate power module ifu (rev.B) instructs users to regularly inspect the power module, and to not use a power module or backup battery that appears damaged.The heartmate power module ifu (section 11.0 ¿routine maintenance¿) instructs users to bring their power module to an authorized service technician at least once per year for a thorough inspection and cleaning.No further information was provided.The manufacturer is closing the file on this event.

• 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: 19939950
• Report Number: 2916596-2024-05109
• Device Sequence Number: 7432630
• Product Code: DSQ
• UDI-Device Identifier: 00813024012566
• UDI-Public: (01)00813024012566(17)260331
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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,Followup
• Report Date (Section B): 10/07/2024

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: Health Professional
• Device Expiration Date: 03/31/2026
• Device Model Number: 109200
• Device Catalogue Number: 109200
• Device Lot Number: GX109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2024
• 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: 07/24/2024
• Supplement Date Received by Manufacturer: 08/08/2024; 10/04/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 08/23/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2023
• 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