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

Model Number 106762

Device Problem Material Deformation (2976)

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

Event Date 05/18/2022

Event Type  malfunction  

Event Description

Related manufacturer reference number for the heartmate ii pump: 2916596-2022-11273.Related manufacturer reference number for the mobile power unit (mpu): 2916596-2022-11348.It was reported that the patient had a potential short to shield driveline issue on (b)(6) 2022.On (b)(6) 2022 at 10:21, there was a no external power alarm when the mobile power unit (mpu) cable came out of the wall according to the patient.On (b)(6) 2022 at 11:16, there was a no external power alarm when the patient lost power due to a thunder storm.Log files captured low voltage alarms on these times that were associated with interruption of the mpu function.On (b)(6) 2022 at 00:02, there was one transient pump stop and one low speed advisory alarm that lasted around 3 seconds around midnight when the patient was sleeping on the mpu.Log file confirmed the alarms, but stated that the patient was tethered on mpu instead of a power module during the alarms.It was confirmed that the patient uses an mpu at home.These alarms only appear to be occurring while the vad is connected to the mpu.The patient did not have any symptoms when the pump stopped while they were sleeping.X-rays were taken and showed a possible area of concern.On (b)(6) 2022, it was noted that the patient's wires has a lot of repair tape and external driveline revision was performed , and no alarms on the grounded patient cable was observed after the repair.During the repair, the controller was exchanged because the power leads were damaged with exposed wiring.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of damaged power cables was able to be confirmed; however, the reported event of atypical alarms was unable to be confirmed.The heartmate ii system controller (serial number: (b)(4)) was returned for analysis, and a log file was submitted for review and another log file was downloaded for review.A review of the submitted log files showed overlapping events spanning approximately 51 days ((b)(6) 2022 ¿ (b)(6) 2022 per timestamp).There were no alarms active in the log file pertaining to the reported event.The controller underwent preliminary and functional testing.The controller underwent continuity testing and did not pass; however, the controller did pass insulation testing.The controller was able to successfully operate a mock loop with no alarms active and was able to operate as intended.The power cables were cut open to inspect the condition of the underlying layers.The power cables were shown to have extensive fluid ingress and multiple kinks.There were no physical abrasions or cuts in the wires; however, during continuity testing, the wires were shown to have severe wire fatigue.No further testing was conducted.Additional information provided on 23may2022 stated that no alarms have been reported following the driveline repair and controller exchange.Additional information provided on 25may2022 stated that the controller was exchanged due to damaged power cables.The root cause of the reported event was unable to be conclusively determined through this investigation; however, the damaged power cables may have contributed to the reported event of atypical alarms.Heartmate ii instructions for use rev.C section 2 entitled ¿system operations¿ and heartmate ii patient handbook rev.C section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms including power cable disconnect, no external power, and pump stop alarm conditions, and the actions to take if the alarms cannot be resolved.Heartmate ii instructions for use rev.C section 8 entitled ¿equipment storage and care¿ and heartmate ii patient handbook rev.C section 6 entitled ¿caring for the equipment¿ addresses how to properly care for, maintain, and store the equipment for proper use.Heartmate iii instructions for use rev.C section 2 entitled ¿system operations¿ and heartmate iii patient handbook rev.C section 2 entitled ¿how your heart pump works¿ states ¿do not twist, kink, or sharply bend the driveline, system controller power cables, power module patient cable, or mobile power unit patient cable, which may cause damage to the wires inside, even if external damage is not visible.¿ 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.The device history records were reviewed for the system controller (serial number: (b)(4)) and was found to pass all manufacturing and qa specifications before being shipped to the customer on 23mar2016.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE II SYSTEM CONTROLLER
• 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: 14678333
• MDR Text Key: 301921975
• Report Number: 2916596-2022-11274
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011286
• UDI-Public: 00813024011286
• 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
• Type of Report: Initial
• Report Date: 06/13/2022

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 Expiration Date: 03/31/2019
• Device Model Number: 106762
• Device Catalogue Number: 106762
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2016
• 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: 61 YR
• Patient Sex: Male
• Patient Weight: 101 KG