MAUDE Adverse Event Report: CARDIACASSIST INC. SHIP KIT, PUMP, TANDEMHEART PUMP; NON-ROLLER TYPE BLOOD PUMP

Model Number 5120-0000

Device Problems High Readings (2459); Pressure Problem (3012)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/05/2020

Event Type  Injury  

Event Description

Livanova received report that, immediately after support initiation, a high infusion pressure alarm was displayed on an escort controller connected to a tandemheart pump.The medical team was not able to resolve the issue, therefore the tandemheart pump was replaced.Through follow-up communication with the customer, livanova learned on (b)(6) 2022 that the patient experienced major bleeding during the event.The additional event description also states that the user attempted to change out the controller without improvement before the pump was exchanged.

Manufacturer Narrative

Livanova manufactures the tandemheart pump.The reported event occurred in (b)(6).Through follow-up communications, livanova learned that there were no kinks on the iv tubing.Additionally, it was reported that tubing was exchanged twice without solving the alarm.A log file analysis was performed, which confirmed a persistent high infusion pressure.All the other measured parameters (flow, current, speed) were within specifications in the log file.The device was not made available for return due to the patient being a covid patient, so an investigation of the complained unit could not be performed.A review of the dhr for the involved tandemheart pump did not identify any deviations or non conformities relevant to the reported issue.Considering all above facts, it cannot be ruled out that reported event was due to a defective pump.However, the pump was not available for return so an exact root cause could not be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: SHIP KIT, PUMP, TANDEMHEART PUMP
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer (Section G): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• Manufacturer Contact: ryan coyle ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 15658264
• MDR Text Key: 302267992
• Report Number: 2531527-2022-00044
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2023
• Device Model Number: 5120-0000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/22/2020
• 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): Other; Required Intervention