MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT; POWER MODULE PATIENT CABLE (14 VOLT)

Model Number 103426

Device Problem Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/27/2018

Event Type  malfunction  

Manufacturer Narrative

Approximate age of device - 3 years, 6 months.The patient remains ongoing with the lvad device.No further information was provided.A supplemental report will be submitted when the manufacturer's investigation is completed.Manufacturing evaluation conclusion: the reported event of the power module patient cable catching fire was confirmed during analysis.The returned patient cable had burn damage and severe kinks between the power connectors and the y junction.The returned patient cable began smoking upon being connected to a test power module.Evaluation of the patient cable revealed inner conductor breakdown.Testing revealed that both power cables had internal wires that shorted to the braided shield beneath the insulation.The patient cable damage was only observed between the black and white power connectors and the y junction; the remainder of the patient cable was unremarkable.Additional information provided stated that the fire was not caused by any vad equipment.The patient will not provide the customer with the root cause of the house fire.The power module associated with this event was investigated under (b)(4); the investigation did not indicate any issues with the power module.The patient cable caught fire due to suspected inner conductor breakdown and electrical shorts caused by exposed conductors; however, the cause of the conductor breakdown is unknown.The root cause of the patient cable catching fire could not be conclusively determined through this analysis.The manufacturer is closing the event.

Event Description

The patient was implanted with a left ventricular assist device (lvad) on (b)(6) 2015.It was reported on (b)(6) 2018 that the patient called the hospital to report that the cord to the power unit was caught on fire.It was reported that the outlet was fine and requested to ship a replacement ppm to the patient's home.On (b)(6) 2018 it was reported that the cause of the fire was unknown.The event was not device related, fire had no effect on vad operation and patient condition.The device was returned for evaluation.The patient was asymptomatic and stable.On (b)(6) 2018 it was reported that a patient cable was received with the power module.No further information was provided.

• Brand Name: HEARTMATE POWER MODULE PATIENT CABLE, 14 VOLT
• Type of Device: POWER MODULE PATIENT CABLE (14 VOLT)
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 95488
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 8354306
• MDR Text Key: 136643507
• Report Number: 2916596-2019-00694
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010784
• UDI-Public: 00813024010784
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 103426
• Device Catalogue Number: 103426
• Device Lot Number: 11017081102
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 40 YR
• Patient Weight: 101