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U.S. Department of Health and Human Services

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

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THORATEC CORPORATION HEARTMATE MOBILE POWER UNIT, NA; VENTRICULAR (ASSIST) BYPASS Back to Search Results
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.
 
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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 Key15107684
MDR Text Key304001950
Report Number2916596-2022-12341
Device Sequence Number1
Product Code DSQ
UDI-Device Identifier00813024010883
UDI-Public813024010883
Combination Product (y/n)N
Reporter Country CodeIN
PMA/PMN Number
P160054
Number of Events Reported1
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 Number107754
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 Received07/26/2022
Supplement Dates Manufacturer Received11/21/2022
10/13/2023
Supplement Dates FDA Received11/22/2022
10/18/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/26/2022
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Patient Age62 YR
Patient SexFemale
Patient Weight47 KG
Patient RaceAsian
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