MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE POWER MODULE; VENTRICULAR (ASSISST) BYPASS

Model Number 1340

Device Problem Mechanical Problem (1384)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2020

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 connection port in the system monitor has a broken pin.The power module will be returned for repair.Manufacturer report number of system monitor: 2916596-2020-05807.

Event Description

It was reported that ground pin on the monitor connector was damaged.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported event, of a damaged monitor connector on the power module, was confirmed.Visual inspection revealed that the monitor cable (connector) assy ground pin was damaged.Replaced i/o internal monitor cable assembly with new; resolved damaged pin issue.The repaired power module s/n (b)(6) passed functional testing per heartmate power module service process and then was returned to the customer site.Power module and system monitor setup, use and maintenance are addressed in the heartmate 3 lvas instructions for use (ifu) and the heartmate power module instructions for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: HEARTMATE POWER MODULE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• MDR Report Key: 10928874
• MDR Text Key: 219000881
• Report Number: 2916596-2020-06038
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024010654
• UDI-Public: 00813024010654
• Combination Product (y/n): N
• PMA/PMN Number: P160054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1340
• Device Catalogue Number: 1340
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEARTMATE SYSTEM MONITOR; HEARTMATE SYSTEM MONITOR