MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSIST) BYPASS

Model Number 107754

Device Problems Use of Device Problem (1670); Insufficient Information (3190)

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

Event Date 07/08/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a continuous alarm occurred while the patient was connected to their mobile power unit (mpu).The green led on the mpu was on, and no alarms were seen on the patient's controller.The patient switched to battery power and powered their mpu on and off.The mpu alarmed again even though the patient was not connected.It was noted that upon startup, only the green led would light up on the mpu.The mpu had a v-lock on the ac power cord, and there were no external or environmental factors that could have contributed to the event.The mpu was replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a continuous audio tone from the mobile power unit (mpu) was not confirmed.It was reported that log files could not be provided and additional information about the alarm was unknown.Additional information provided also stated that ac power to the mpu was not lost during the event.It was reported that the mpu would be returned for evaluation; however, customs delays prevent the product from being returned at this time.The file will be reopened if the product is returned at a later date.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.(b)(6) was shipped to the customer on 11may2022.Heartmate 3 patient handbook (rev.G), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.G), under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Heartmate 3 instructions for use (rev.G) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.G) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the mobile power unit (mpu).Heartmate 3 patient handbook (rev.G) and section 10 and heartmate 3 instructions for use (rev.G) 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 3 patient handbook (rev.G) 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.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of a continuous audio tone from the mobile power unit (mpu) and only the green led lighting up during the self-test was not confirmed.The returned mpu (serial number: (b)(6)) was functionally tested and was found to operate as intended during analysis.The mpu was booted up and the self-test was successfully completed several times; all leds activated as intended during testing.The mpu was tested on a mock circulatory loop without any issues or atypical alarms produced.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.(b)(6) was shipped to the customer on (b)(6) 2022.Heartmate 3 patient handbook (rev.G), under section 5 ¿alarms and troubleshooting¿ and heartmate 3 instructions for use (ifu) (rev.G), under section 7 ¿alarms and troubleshooting¿, cover all alarms (visual and audible), and the actions to take if the alarms cannot be resolved.Heartmate 3 ifu (rev.G) section 8 ¿ ¿equipment storage and care¿ and heartmate 3 patient handbook (rev.G) section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment, including the mobile power unit (mpu).Heartmate 3 patient handbook (rev.G) and section 10 and heartmate 3 ifu (rev.G) 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 3 patient handbook (rev.G) 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 MOBILE POWER UNIT, NA
• 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: 15107684
• MDR Text Key: 304001950
• Report Number: 2916596-2022-12341
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 813024010883
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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: 10/18/2023

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: 107754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/12/2022
• Initial Date FDA Received: 07/26/2022
• Supplement Dates Manufacturer Received: 11/21/2022; 10/13/2023
• Supplement Dates FDA Received: 11/22/2022; 10/18/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2022
• 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
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 47 KG
• Patient Race: Asian