MAUDE Adverse Event Report: THORATEC CORPORATION HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS); VAD COORDINATOR

Model Number 106015

Device Problems Decreased Pump Speed (1500); Pumping Stopped (1503); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Gastrointestinal Hemorrhage (4476)

Event Date 02/23/2024

Event Type  malfunction  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

T was reported that there were two low speed operations noted on the night of (b)(6) 2024.The patient was inpatient and being treated for gastrointestinal (gi) bleed.No other pump abnormalities were noted.Log files showed two transient low speed advisories on (b)(6) 2024 at around 8:15 pm.Speed drops were as low as 120 rpm.These events were confirmed to be due to the motor stopped command (stop pump) feature being enabled, which reportedly was accidental.The events prior to the pump stop command being initiated were unclear.No patient issues/harm was resulted from the low speed events.As for treatment for bleeding, anticoagulation was held.Endoscopy, colonoscopy and computed tomography angiography (cta) were performed to identify the source of bleeding, but they were unable to reach the area of concern via gastrointestinal procedures.The bleeding was reported as resolved with plans to monitoring for reoccurrence of bleed.Related mfr 2916596-2024-01629.

• Brand Name: HEARTMATE II LVAS IMPLANT KIT (WITH SEALED GRAFTS)
• Type of Device: VAD COORDINATOR
• Manufacturer (Section D): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer (Section G): THORATEC CORPORATION; 6035 stoneridge drive; pleasanton CA 94588
• Manufacturer Contact: lindsey sallese ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528207
• MDR Report Key: 18932740
• MDR Text Key: 338750399
• Report Number: 2916596-2024-01255
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00813024011224
• UDI-Public: 00813024011224
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060040
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2021
• Device Model Number: 106015
• Device Lot Number: 6545099
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/24/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 109 KG