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

Model Number 107758

Device Problems Mechanical Problem (1384); Connection Problem (2900); Difficult or Delayed Separation (4044)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

The results/method/conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that the black screw of the mpu (mobile power unit) seemed very tight when connecting the black connector to the black screw of the mpu.Mpu-34612 was to be replaced and sent back for investigation.

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 thread of the black connector is damaged.The system powered up as intended and passed the self test.The functionality of the system is as intended.Software version 1.02.01 was installed.The mobile power unit patient cable must be replaced.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event, of the black power cable lead connector mpu being damaged, was confirmed when the unit was evaluated by technical service.The threads on the black power cable lead connector were damaged and marred.Functionally, the damaged threads did not affect threading and locking the mating controller connector onto the mpu.The white power lead connector on the mpu was not damaged.The mpu was repaired by replacing the patient cable assembly.The repaired unit was functionally tested and returned to the customer.The cause of the thread damage was unable to be determined through this analysis.The mpu assembly was made in jul 2019.The unit was packaged and placed into stock on jul 27, 2019.The unit was sent to the customer on sep 5, 2019.The unit had no previous services.Set up and use of the mobile power unit (mpu) are documented in the heartmate 3 lvas patient handbook and the heartmate 3 lvas instructions for use (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.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, EU
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 11159782
• MDR Text Key: 226823184
• Report Number: 2916596-2020-06514
• 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: foreign,health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 107758
• Device Lot Number: 7104711
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1