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

Model Number 107754

Device Problems Device Alarm System (1012); Protective Measures Problem (3015); Insufficient Information (3190)

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

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

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's mobile power unit (mpu) was alarming while the patient was not connected to it.The alarm was an intermittent tone with a yellow wrench.The patient attempted to replace the aa batteries and troubleshoot, but was not successful.The batteries needed to be removed in order to get the alarms to stop.The site reported that the mpu would be returned for evaluation and repair.

Manufacturer Narrative

Manufacturer investigation conclusion: the reported event, of the mobile power unit (mpu) alarming, was inconclusive (not determined) as no product was evaluated.Multiple requests for additional event information and the return of the unit for evaluation were sent to the customer; no additional event information was received.The mpu was not returned for evaluation.The mpu assembly was made in jul 2020.The unit was packaged and placed into stock on aug 12, 2020.The unit was sent to the customer on sep 8, 2020.The unit had no previous services.Set up and use of the mobile power unit (mpu) with the heartmate 3 left ventricular assist system (lvas) are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas instructions for use (ifu).Alarms and the proper actions to be taken if alarms cannot be resolved are documented in the heartmate 3 lvas patient handbook (p.207 - ¿alarms and troubleshooting¿; p.219 ¿no external power alarm¿; p.233 ¿mpu alarms¿) and the heartmate 3 lvas ifu (p.7-1 ¿alarms and troubleshooting¿; p.7-13 ¿no external power alarm¿; p.7-33 ¿mpu alarms¿).Specific warnings and cautions regarding the mpu's set up, the electrical outlet used (including location and accessibility) and electrostatic electricity damage to the mpu are given in both the heartmate 3 lvas patient handbook (p.79 - 81) and the heartmate 3 lvas ifu (p.3-36 to 3-38).The heartmate 3 lvas patient handbook states that the patient should contact their hospital should they believe their equipment has issues - "if for any reason, any portion of your equipment is not functioning as usual, is broken, or you 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
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11059793
• MDR Text Key: 223727919
• Report Number: 2916596-2020-06055
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2020
• 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
• Date Manufacturer Received: 02/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Weight: 95