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

Model Number 106762OUS

Device Problems Disconnection (1171); Mechanical Problem (1384); Pumping Stopped (1503); Material Deformation (2976); Noise, Audible (3273); Complete Loss of Power (4015)

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

Event Date 11/02/2021

Event Type  malfunction  

Event Description

It was reported that one device was replaced due to a pump stop.Suspected driveline damage was found through the log file evaluation.It was reported that one system controller had dry remaining material at the internal part of the driveline connector that was found through investigation.It was reported that one system controller was replaced due to power off alarms that occurred several times during outpatient management.It was reported that one system controller was replaced due to a red heart alarm.A troubleshoot attempt was performed by changing the power source from battery to power module, but the alarm persisted until device was exchanged.The log file review identified driveline disconnection and pump stop alarms.The system controller continued to monitor the system for 23 minutes after the pump stopped and before the power was replaced.It was reported that one system controller was replaced due to a sound stop.It was reported that one system controller was replaced due to an unusual noise when the power cale was disconnected.The log file analysis found abnormalities in voltage.It was reported that one system controller was replaced due to a damaged cable.The coating on the outside of the black power cable was thinned, a hole was opened, and the internal shield was exposed.It was reported that one system controller was replaced due to a red heart alarm on batteries and the power module.There was suspicion of driveline damage.It was reported that one system controller had a broken lock of the driveline connector.Although the driveline could be physically connected, the lock would not function, and the driveline could not be fixed.It was reported that one system controller was replaced after a suspected device malfunction.The device operated properly when connected to the demo device.

Manufacturer Narrative

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

Manufacturer Narrative

Section a2, a3, a4, a5, a6: this event was created to document the historical events reported from j-macs.Specific patient information is not available.Section d4: this event was created to document the historical events reported from j-macs.Specific device serial number(s) and expiration date(s) are not available.Section h4: this event was created to document the historical events reported from j-macs.Specific device manufacturing date(s) are not available.Manufacturer's investigation conclusion: the reported event of dry remaining material in the internal part of the driveline connector, power off alarms active, a sound stop, unusual noise, damaged power cable, a damaged driveline connector lock, and a suspected device malfunction were not confirmed.The heartmate ii pocket controllers were not returned for analysis.In addition, there were no log files, photos or any supporting documents submitted that would indicate an issue with the controllers.The root cause of the reported event could not be conclusively determined through this analysis.Heartmate ii patient handbook under section 5 ¿alarms and troubleshooting¿ and heartmate ii instructions for use (ifu), under section 7 ¿alarms and troubleshooting¿ cover all alarms (visual and audible), including the alarm conditions, and the actions to take if the alarms cannot be resolved.Furthermore, subsection ¿what not to do: driveline and cables¿ informs the user to check the system controller power cables for twisting, kinking, or bending which could cause damage to the wires inside.This section informs the user not to ¿twist, kink, or sharply bend the system controller power cables¿ and states ¿if the driveline or cables become twisted, kinked, or bent, carefully unravel and straighten¿.Heartmate ii patient handbook section 6 "caring for the equipment" and heartmate ii instructions for use (ifu) section 8 ¿equipment storage and care¿ describe how to care for and clean all equipment, including the system controller.Heartmate ii patient handbook section 10 and heartmate ii instructions for use (ifu) section f, both entitled ¿safety checklists¿, provide checklists to assist the patient in performing routine maintenance of heartmate ii lvad, including inspecting the system controller.This section also informs the user to replace any equipment or system component that appears damaged or worn.Heartmate ii patient handbook section 4 ¿living with the heartmate ii¿ informs the user that the system controller must be kept dry at all times.Never swim or take baths.Do not shower without doctor¿s approval, and never shower without the shower bag; do not submerge shower bag in water.This section also states ¿although the external components of the heartmate ii left ventricular assist system are moisture-resistant, they are not waterproof.Take care to protect system components from water or moisture, whether indoors showering or outdoors in a heavy rain.If the components have contact with water or moisture, you may receive an electrical shock or the pump may stop.¿ heartmate ii patient handbook 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, CAN
• 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: 14021973
• MDR Text Key: 288672729
• Report Number: 2916596-2022-01842
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 05/20/2022

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 Model Number: 106762OUS
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/18/2022
• Initial Date FDA Received: 04/06/2022
• Supplement Dates Manufacturer Received: 05/10/2022
• Supplement Dates FDA Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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