MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE UNIVERSAL BATTERY CHARGER; VENTRICULAR (ASSIST) BYPASS

Model Number	1440
Medical Device Problem Codes	Material Discolored (1170); Mechanical Problem (1384); Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2023
Type of Reportable Event	Malfunction
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that the patient's battery charger did not work after the sparking at the charger and at the wall outlet.The outlet has been replaced by an electrician.The battery charger did not work with other outlets.The charger was extremely dirty and the battery cable cord was damaged.The battery charger was replaced.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of the universal battery charger (ubc) not powering on and the ubc being in poor condition was confirmed.During the evaluation of the returned (b)(6) , the ubc was unable to power on when plugged into the wall outlet.The unit was opened, and a pest infestation was observed on the main pcb and housing.The ubc was in poor condition and therefore was not repaired.The customer was notified that the unit was scrapped.Pest control records were reviewed during the time the unit was within abbott control and determined that the pests did not originate during the manufacturing process.The root cause for the ubc becoming non-functional was unable to be conclusively determined through this analysis.The patient handbook 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.Heartmate ubc instructions for use (ifu), rev.E, provides an overview of how to use and care for the ubc.Section 5 ¿monitoring performance¿ covers all faults, including charger pocket faults, and the actions to take when a fault occurs.Heartmate 3 instructions for use, rev.C, section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook rev.D section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms, including faults that occur on the ubc, and the actions to take if the faults do not resolve.The universal battery charger (ubc) instructions for use (ifu), rev.E, explains under the responding to advisory messages how to troubleshoot any errors or alarms.It states under the precautions section: "the metal contacts inside the ubc pockets should be kept clean and dry.Do not expose contacts to water, moisture, dirt, etc.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE UNIVERSAL BATTERY CHARGER
• 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: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 17458399
• Report Number: 2916596-2023-05351
• Device Sequence Number: 2710100
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 10/20/2023

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2023
• 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: 07/12/2023
• Supplement Date Received by Manufacturer: 10/19/2023
• Initial Report FDA Received Date: 08/04/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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: 48 YR
• Patient Sex: Male
• Patient Weight: 75 KG