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

Model Number L25626

Device Problems Crack (1135); Mechanical Problem (1384); Material Deformation (2976); Scratched Material (3020)

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

Event Date 05/25/2022

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 system monitor had deformation and a crack.The screen was scratched.The io test did not pass.The motherboard had to be replaced.The inverter cable was cracked.

Manufacturer Narrative

Section g3: there was no patient involved in this event.The pma# provided is associated with most recent approval.Manufacturer's investigation conclusion: the reported event of the system monitor having a damaged housing, screen, and the i/o test not passing due to a broken inverter cable was confirmed via visual analysis of the returned unit.The heartmate system monitor (serial number (b)(6)) was returned and evaluated at the european distribution center (edc) on 25may2022.During the evaluation, the monitor was visually inspected and appeared to have a scratched screen and damaged housing.A power on/off inspection was performed, and the unit powered up as intended.A functional test was performed on the unit and the i/o test did not pass.The motherboard was replaced.Additionally, the inverter cable was cracked, exposing the inner conductor of the wire (see attached figure 4).Software version v7.32 was observed on the unit.The motherboard, front cover, led cable, touch screen, and inverter cable were replaced with known working components.Preventative maintenance was performed on the unit and all tests were performed per procedure.No further testing was completed at this time.A manufacturing analysis task was opened to further address the crushed inverter cable.The investigation found that the crushing of this cable could occur during manufacturing or servicing of these units; however, it could not be determined which method caused the crushing of this inverter cable.No capa/ecar/scar is required due to the low risk of this event.A risk assessment was initiated due to the results of the manufacturing investigation.There is no risk assessment necessary as there is already an adequate risk assessment contained in product risk assessment (pra).The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed the heartmate system monitor (serial#: (b)(6)) was manufactured in accordance with manufacturing and qa specifications.(b)(6) was shipped from abbott on 05nov2017.The heartmate 3 instructions for use section 4-¿system monitor¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.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.No further information was provided.The manufacturer is closing the file on this event.

Manufacturer Narrative

The motherboard and inverter cable were received for evaluation on 15july2022.Manufacturer' investigation conclusion: the reported event of the system monitor having a damaged housing, screen, and the i/o test not passing due to a broken inverter cable was confirmed via visual analysis of the returned unit.The heartmate system monitor (serial number (b)(6) was returned and evaluated at the european distribution center (edc) on 25may2022.During the evaluation, the monitor was visually inspected and appeared to have a scratched screen and damaged housing.A power on/off inspection was performed, and the unit powered up as intended.A functional test was performed on the unit and the i/o test did not pass.The motherboard was replaced.Additionally, the inverter cable was cracked, exposing the inner conductor of the wire.The motherboard, front cover, led cable, touch screen, and inverter cable were replaced with known working components.The motherboard and inverter cable were forwarded to product performance engineering (ppe) for further analysis.The motherboard and inverter cable were placed in a known working test fixture and the system operated as intended without any issues.The damage to the inverter cable did not affect the functionality of the device.A manufacturing analysis task was opened to further address the crushed inverter cable.The investigation found that the crushing of this cable could occur during manufacturing or servicing of these units; however, it could not be determined which method caused the crushing of this inverter cable.No capa/ecar/scar is required due to the low risk of this event.A risk assessment was initiated due to the results of the manufacturing investigation.There is no risk assessment necessary as there is already an adequate risk assessment contained in product risk assessment (pra).The root cause of the reported event could not be conclusively determined through this analysis.The device history records were reviewed and the records revealed the heartmate system monitor (serial#: (b)(6)was manufactured in accordance with manufacturing and qa specifications.(b)(6) was shipped from abbott on 05nov2017.The heartmate 3 instructions for use section 4-¿system monitor¿ and heartmate 3 patient handbook section 6-¿caring for the equipment¿ explain how to properly handle the monitor to prevent damage.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.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE SYSTEM MONITOR
• 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: 14547712
• MDR Text Key: 293378017
• Report Number: 2916596-2022-11299
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010852
• UDI-Public: 00813024010852
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L25626
• Device Catalogue Number: 1286A-US
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2006
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1