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

Model Number	107754
Medical Device Problem Code	Electrical Power Problem (2925)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The results/method and conclusion codes along with investigation results will be provided in the final report.
Event or Problem Description
Log files were reviewed which found a power cable disconnect on the mpu.It was noted that the mpu had a locking connector.The power cable disconnect was attributed to a power outage at the patient's residence.
Event or Problem Description
Log files were reviewed which found a power cable disconnect and low power hazard alarms on the mpu.It was noted that the mpu had a locking connector.The alarms were attributed to a power outage at the patient's residence.
Additional Manufacturer Narrative
Manufacturer's investigation conclusion: the reported event of a no external power event involving low voltage and no external power alarms was confirmed via the log file analysis.The mobile power unit (mpu) (serial number: (b)(6) was not returned for analysis; however, a log file (b)(6) was submitted for review.A review of the log file showed 240 events spanning approximately 18 days (b)(6) 2021 per the timestamp).A total loss of power event was active on (b)(6) 2021 from 05:09:35 ¿ 05:09:39 that was associated with low power hazard and no external power alarms.The bus voltage and the rsoc voltages decreased to 12v and 2.5v respectively, before power was restored to mpu.The no external power alarm activated despite both cables being connected to the mpu.The backup battery supported the system during these events.These alarms appear to be caused due to a loss of ac power while connected to the mpu.The alarms cleared once power was restored.Pump operation was not affected.No other notable alarms were observed in the log file.Additional information provided on 27jul2021 stated that the mpu (serial number: (b)(6) has a v-lock connector on the ac power cord, and that the patient stated the cause of the no external power alarms was due to a power outage at their home.The root cause for the no external power alarms were due to a power outage at the patient¿s home; however, the root cause for the loss of ac power was unable to be conclusively determined through this investigation.The device history records were reviewed and the records revealed the mobile power unit (serial number: (b)(6) was manufactured in accordance with manufacturing and quality assurance specifications.The device was shipped on 02jan2018.Heartmate ii instructions for use section 8 ¿ ¿equipment storage and care¿ and heartmate ii patient handbook section 6 ¿ ¿caring for equipment¿ explain how to properly care for the equipment.Additionally, heartmate ii patient handbook section 10 entitled ¿safety checklists¿, instructs users to regularly inspect their accessories for damage, and to replace any equipment that appears damaged or worn.Heartmate ii instructions for use section 7 entitled ¿alarms and troubleshooting¿ and heartmate ii patient handbook section 5 entitled ¿alarms and troubleshooting¿ addresses how to properly interpret and troubleshoot all system alarms, including low voltage alarms and no external power alarms.Heartmate ii instructions for use section 3 ¿ ¿powering the system¿ and heartmate ii patient handbook section 3 ¿ ¿powering the system¿ addresses the user to not use expired batteries and advises the user to properly dispose of them.Heartmate ii patient handbook and heartmate ii instructions for use (ifu) caution 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
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 12284443
• Report Number: 2916596-2021-04003
• Device Sequence Number: 3841525
• Product Code: DSQ
• UDI-Device Identifier: 00813024013006
• UDI-Public: 00813024013006
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: P160054
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/08/2021

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
• Operator of Device: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754OUS
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/09/2021
• Initial Report FDA Received Date: 08/05/2021
• Supplement Report FDA Received Date: 10/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR
• Patient Weight: 93