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

Model Number 107754

Device Problems Electrical Power Problem (2925); Complete Loss of Power (4015)

Patient Problems Respiratory Distress (2045); Confusion/ Disorientation (2553)

Event Date 08/18/2020

Event Type  malfunction  

Manufacturer Narrative

Pma/510(k) #: p160054.No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is complete.

Event Description

It was reported that the patient was admitted for acute respiratory distress and change in mental status.The log file showed no external power and low voltages.Upon review by technical services, the log file showed low voltage hazards and no external power events on (b)(6) 2020 due to loss of power to the mpu.Power was restored to the mpu after several seconds and then about 20 seconds later, there was no external power from both leads being disconnected until power leads were connected back to the mpu.There was no interruption to the vad function as the backup battery in the controller was enabled until power was restored in both occasions.There was a low voltage hazard on (b)(6) 2020 and (b)(6) 2020 due to loos of power to the mpu.

Manufacturer Narrative

Sections d4 (udi), h5, h8: corrected data.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event, of loss of external power alarms, was confirmed in the submitted log file.The customer submitted heartmate 3 lvas log files for review ¿ noting that the patient was admitted to the hospital with acute respiratory distress.Technical service reviewed the log file and noted loss of external power events while connected to the mpu.The event log file contained approximately 27 days of patient event data.There were four loss of external power events that occurred with the patient on the mpu.The events were from 4 to 19 seconds in duration.The controller operated on backup battery power due to the events.The mpu was the power source before and after the events.No equipment was returned for evaluation.The reason for the loss of external power events could not specifically be determined from the log file.Multiple requests for additional event information were sent to the customer.No additional event information was provided.Set up and use of the mobile power unit (mpu) with the heartmate 3 lvas system are documented in the heartmate 3 lvas patient handbook and the heartmate 3 ifu.Alarms and the proper actions to be taken if alarms cannot be resolved are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.Specific warnings and cautions regarding the mpu's set up, the potential tripping hazards presented by the mpu patient cable and power cord, and the electrical outlet used (including location and accessibility) are given in both the heartmate 3 lvas patient handbook and the heartmate 3 lvas ifu.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: 10495476
• MDR Text Key: 206525030
• Report Number: 2916596-2020-04199
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: Yes
• 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
• Date Manufacturer Received: 12/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 62 YR
• Patient Weight: 102