MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II SYSTEM CONTROLLER; VENTRICULAR (ASSISST) BYPASS

Model Number 106762

Device Problem Electrical Power Problem (2925)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2020

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 had been experiencing alarms while connected to patient cable at home and was unable to identify the specific alarm.The device history showed multiple low voltage advisories and a couple of low voltage alarms.The voltages seen while using the patient cable were well below the 14 volt specification.The controller, patient cable and battery clip were all exchanged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of low voltage and power cable disconnect alarms was confirmed via the log file.The log file spanned approximately 14 days ((b)(6) 2020 to (b)(6) 2020 per the timestamp).Voltage fluctuated throughout the log file while the device was connected to the power module and battery power source.This coincided with low voltage advisory alarms throughout the log file due to voltage fluctuation below the expected threshold of 14v while the device was connected to the power module power source.Atypical power cable disconnect alarms intermittently activated between (b)(6) 2020 at 01:54 and (b)(6) 2020 at 10:43 due to power cable fault on both power cables not associated with a power source exchange while the device was connected to a battery power source.The alarms resolved shortly after activation and did not affect the controller¿s ability to operate at the set speed limit.No other notable alarm was observed.The hmii system controller, serial (b)(6), was not returned for analysis.Per provided information, the controller was exchanged and will not be returned for evaluation.A root cause of the reported event was not determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or qa specifications.(b)(6) was shipped to the customer on (b)(6) 2017.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 ii instructions for use section 8-¿equipment storage and care¿ and heartmate ii patient handbook section 6-¿ equipment storage and care¿ explain how to properly store, clean, and maintain system controller.Heartmate ii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including power cable disconnect and low voltage alarms.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11089016
• MDR Text Key: 224325141
• Report Number: 2916596-2020-06248
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• 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: 01/27/2021

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
• Device Operator: Lay User/Patient
• Device Expiration Date: 04/30/2020
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Device Lot Number: 6011966
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/09/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/26/2021
• Supplement Dates FDA Received: 01/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 71