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

Model Number 107754

Device Problem Loss of Power (1475)

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

Event Date 06/21/2021

Event Type  malfunction  

Manufacturer Narrative

Serial#: was requested but was not provided.Manufacturer's investigation conclusion: the reported event of a no external power alarm regarding the mpu was confirmed via the provided log files.Two log files were reviewed, collectively containing data that spanned approximately 26 days (02jun2021 ¿ 28jun2021 per time stamp), as well as an additional unknown amount of time, as the controller¿s clock was not synced throughout the first several events of both files, reading as its default timestamp of 01jan2001.A no external power alarm was observed within the timeframe where the clock was not synced while the mpu was in use.The alarm appeared to have been caused by a loss of ac power, as the rsoc steadily decreased.The alarm resolved when power was restored to the system.The mpu (serial number unknown) was not returned for analysis.Multiple questions regarding the mpu and the event were asked multiple times and no responses were received.The root cause of the observed loss of ac power was unable to be conclusively determined through this analysis.The heartmate ii patient handbook (rev.F, section 5 ¿alarms and troubleshooting¿) describes all alarms (visual and audible) and what action should be performed when they do occur, including the no external power alarm: to resolve the no external power alarm: immediately connect the system controller power cables to a working power source (functioning mobile power unit or two fully-charged heartmate 14 volt lithium-ion batteries).Call your hospital contact immediately if connecting to power does not resolve the alarm.The heartmate ii patient handbook (rev.F, section titled ¿emergency contact list¿) 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.

Event Description

It was reported that log files were reviewed, and a no external power alarm caused by a loss of ac power while the mpu was in use was observed during a timeframe where the controller's clock was not synced.The pump operated as intended during this time.

• Brand Name: HEARTMATE MOBILE POWER UNIT, NA
• Type of Device: VENTRICULAR (ASSISST) 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: 12711000
• MDR Text Key: 278773214
• Report Number: 2916596-2021-06071
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010883
• UDI-Public: 00813024010883
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2021
• 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/13/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 67 YR
• Patient Weight: 78