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

Model Number 107754

Device Problems Loss of Power (1475); Complete Loss of Power (4015)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2020

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 patient experienced multiple no external power and low voltage advisories.The 2 alarms appeared to be associated with one another, although it was also noted that the ¿low voltage advisory¿ alarms were isolated.A log file analysis captured several low voltage hazard/no external power events on (b)(6) 2020 while using the mobile power unit.It appears there was a total loss of power to the mobile power unit enabling the backup battery in the controller until power was restored.Also noted were low voltage advisory/hazard events while on battery on (b)(6) 2020 @ 1701 due to battery depletion.Patient switched to fully charged batteries shortly after these events.The patient's mobile power unit has a locking mechanism for the ac cord and the patient has been re-educated on safe power tethering practices as well as battery management.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event of no external power alarms was confirmed via the log file.The submitted log file spanned approximately 11 days (b)(6) 2020 per the timestamp).No external power alarms activated on (b)(6) 2020 at 13:33, (b)(6) 2020 at 21:02, and (b)(6) 2020 at 13:35 due to rsoc and bus voltage diminishing to ~0v while the device was connected to the mobile power unit.This is consistent with the power cord disconnecting from the wall outlet or the device itself.The backup battery was able to provide power to the pump.The alarm resolved shortly after reconnecting to the power source.No other notable alarm was observed.The mobile power unit was not returned for analysis.Additional information on 11nov2020 stated that the patient has the v-lock cable and denies using an extension cord to power the mpu or have the mpu on an outlet with a switch.The patient has been re-educated on safe power tethering practices as well as battery management.An attempt was made to obtain additional information regarding the mobile power unit; however, the site stated that no further information can be given.A root cause of the reported event was not determined through this analysis.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.Heartmate iii instructions for use section 7-¿alarms and troubleshooting¿ and heartmate iii patient handbook section 5-¿alarms and troubleshooting¿ explain how to properly interpret and troubleshoot alarms including no external power.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 (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10963245
• MDR Text Key: 220220340
• Report Number: 2916596-2020-05729
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

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
• Device Operator: Lay User/Patient
• Device Model Number: 107754
• Device Catalogue Number: 107754
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/11/2020
• Initial Date FDA Received: 12/07/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 74