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

Model Number 106017

Device Problems Alarm Not Visible (1022); Electrical Power Problem (2925)

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

Event Date 01/29/2023

Event Type  malfunction  

Event Description

It was reported that during a clinic visit, the healthcare provider noted a pump stop in the patient's alarm history that had occurred a few days prior.The patient did not report any alarms and had not experienced any symptoms.Log file analysis captured low voltage hazard alarms.The patient's controller and battery clips were exchanged.The patient would be kept in the hospital for observation.Related pump mfr #: (b)(4).

Manufacturer Narrative

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

Event Description

Additional information: the exchange of the battery clips resolved the low voltage alarms.The log files could not conclude a cause of why the motor stopped.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of the patient not hearing alarms was not confirmed.It was reported that when the patient presented in clinic, the healthcare professional noticed a pump stop a few days prior to the clinic visit in addition to low voltage alarms in the controller history.The patient reported not having any alarms or noticing anything being different.The controller was reported to be exchanged and subsequently discarded.No product was returned for evaluation and log files from the exchanged controller were not provided.The root cause of the reported event could not be conclusively determined through this analysis.Device history records were reviewed and showed no deviations from manufacturing or quality assurance (qa) specifications.Heartmate ii patient handbook (rev.C), under section 5 ¿alarms and troubleshooting¿ and heartmate ii instructions for use (ifu) (rev.B), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the pump off and low voltage hazard alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii patient handbook (rev.C) section 6 "caring for the equipment" and heartmate ii ifu (rev.B) section 8 "equipment storage and care" describe how to care for and clean all equipment.This section instructs the user to, at least monthly, inspect the system controller¿s audio sounders for dirt or grease.If a change in tone or in loudness is noticed during a system controller self-test, the audio speaker sockets may be obstructed.Audio speaker sockets may be cleaned using a small cotton swab that is moistened (not dripping) with rubbing alcohol.Never insert anything sharp (like a toothpick or pin) into the sounder holes.This can damage the speakers inside.Heartmate ii patient handbook (doc #10006962, rev.C) section 2 "how your heart pump works" and heartmate ii instructions for use (ifu) (doc #10006960, rev.C) section 2 "system operations" explain that the system controller self test should be performed at least once per day to check the audible and visual alarm indicators on the user interface, as well as the status of the backup battery.Heartmate ii patient handbook (rev.C) section 10 and heartmate ii ifu (rev.B) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate 3 lvad.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate ii patient handbook (rev.C) and heartmate ii ifu (rev.B) under section 3, entitled ¿powering the system¿, state that the patient must always connect to the mobile power unit or power module for sleeping or when there is a chance of sleep, as a sleeping patient may not hear the system controller alarms.Heartmate ii patient handbook (rev.C) 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.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER, EU
• 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: 16279663
• MDR Text Key: 308844976
• Report Number: 2916596-2023-00656
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2019
• Device Model Number: 106017
• Device Lot Number: 5746308
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/08/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male