MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE 14 VOLT LITHIUM ION BATTERY SET; VENTRICULAR (ASSIST) BYPASS

Model Number 2465

Device Problem Failure to Charge (1085)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/16/2022

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the 14-volt battery being unable to charge with a displayed error code was confirmed.The returned 14-volt battery (serial number (b)(4)) was received with 0 of its leds lit upon pressing the fuel gauge button.The battery was unable to charge within a known working test universal battery charger (ubc), and an error code was observed indicating that the battery¿s printed circuit board (pcb) was damaged.The battery was opened, and a component that connects to the battery¿s cells and contacts was observed to have been electrically damaged, as the component had partially shorted to other areas of the cell/contact circuitry.Due to this component being damaged, the battery was unable to properly charge and output voltage.The provided log file was reviewed, containing data spanning approximately 8 days ((b)(6) 2022 per timestamp).The pump maintained speeds above the low speed limit while connected to the driveline.Issues regarding the battery¿s ability to charge were not observed throughout the data.The root cause of the reported event was determined to be damage to the battery¿s main pcb; however, the root cause of the damage was unable to be conclusively determined.Device history records (dhr) reside with the original equipment manufacturer (oem).However, the battery was observed to have passed all initial manufacturing tests per the manufacturing inspection datasheet.The heartmate ii patient handbook (rev.F) instructs users on how to properly use, charge, and calibrate 14-volt batteries.If a red light status becomes active on the ubc while the battery is charging, users are advised to not use that battery.The patient handbook also instructs users on how to check the current relative charge of the 14-volt batteries.Two batteries are expected to power the system for approximately 10-12 hours, and this can vary depending on activity level.The heartmate ii patient handbook (rev.F, section 5 ¿alarms and troubleshooting¿) instructs users on how to resolve alarms that sound from their system controller, including alarms associated with power cable disconnect/low voltage conditions.The heartmate ii patient handbook (rev.F, section 6 ¿caring for the equipment¿) instructs users on how to properly clean and maintain the integrity between the battery and clip combo.A poor connection may result in atypical low voltage alarms.The heartmate ii patient handbook (rev.F, section titled "emergency contact list") 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.

Event Description

It was reported that the battery would not charge and would bring up an error code.The battery was removed and a replacement was issued to the patient.

• Brand Name: HEARTMATE 14 VOLT LITHIUM ION BATTERY SET
• Type of Device: 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: 14633871
• MDR Text Key: 294783029
• Report Number: 2916596-2022-11583
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010692
• UDI-Public: 00813024010692
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2465
• Device Catalogue Number: 2465
• Device Lot Number: GV230-B043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/18/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 117 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White