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

Model Number 1440

Device Problems Mechanical Problem (1384); Smoking (1585); Noise, Audible (3273)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.

Event Description

It was reported that the patient spilled liquid on the battery charger, which made an electric zapping sound and started to smoke.The patient then used a set of batteries from the charger and started having frequent low voltage and power cable disconnect alarms.The batteries and charger were exchanged and the patient had no further alarms.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of fluid ingress in the battery charger was not confirmed.The universal battery charger (serial number (b)(6) ) was not returned for analysis; however, a log file was submitted.In addition, there were no photographs or any sort of evidence submitted that would indicate an issue with the battery charger.The submitted log file (labeled (b)(4) ) contained data spanning approximately 1 day ((b)(6) 2021 ¿ (b)(6) 2021 per the timestamp).The log file captured intermittent atypical low power advisory alarms while connected to battery power on (b)(6) 2021 due to the rsoc voltage and the bus voltage in the black power cable dropping below the expected voltage.These low power advisory alarms do not follow routine battery depletion.In addition, the log file captured atypical intermittent power cable disconnect alarms on (b)(6)2021 due to the rsoc and bus voltage dropping to approximately 0 volts.The alarms appear to resolve on their own when the rsoc and bus voltage is restored to the expected values.Multiple attempts were made to gather additional information about the reported event such as if replacing the batteries resolved the low voltage and power cable disconnect alarms, and if any products will be returning for evaluation; however, no response was given.Additional information provided on 21jun2021 stated that the battery charger was removed along with the affected batteries and the patient was provided with replacements.The serial number of the ubc is: (b)(6).The root cause of the reported event could not be conclusively determined through this analysis; however, the liquid that got spilled into the battery charger could have contributed to the alarms.The device history records were reviewed and the records revealed the heartmate universal battery charger (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.(b)(6) was shipped to the customer on 10nov2019.Heartmate ubc instructions for use 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 section 7 ¿ ¿alarms and troubleshooting¿ and heartmate 3 patient handbook section 5 ¿ ¿alarms and troubleshooting¿ cover all alarms, including faults that occur on the ubc, and the actions to take if the faults do no resolve.Heartmate universal battery charger (ubc) instructions for use under "warnings" states "keep the universal battery charger (ubc) away from water or moisture.If the ubc has contact with water/moisture, rain/snow, shower spray, or wet surfaces, you may get a serious electric shock or your charger may fail to operate properly¿.The patient handbook and the instructions for use caution the user 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 UNIVERSAL BATTERY CHARGER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12197297
• MDR Text Key: 262474542
• Report Number: 2916596-2021-03821
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010678
• UDI-Public: 00813024010678
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1440
• Device Catalogue Number: 1440
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 128