MAUDE Adverse Event Report: CARDIACASSIST INC. ESCORT CONTROLLER; NON-ROLLER TYPE BLOOD PUMP

Model Number 5140-8500

Device Problems Pumping Stopped (1503); Unexpected Shutdown (4019)

Patient Problems Low Blood Pressure/ Hypotension (1914); Hypoxia (1918)

Event Date 03/21/2021

Event Type  malfunction  

Manufacturer Narrative

Cardiacassist inc.Manufactures the escort controller.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that the escort controller was warm to touch and shut off during ecmo support.Acute hypoxia and hypotension were observed on the patient.The controller was switched to lifesparc and oxygenators were replaced.

Manufacturer Narrative

H10: the sn provided in the initial report was incorrect.The serial number of the involved device is still unknown despite requested several times.However, dhr review for all escort controllers installed at facility was performed and did not reveal any deviations or non-conformities relevant to the reported issue.Based on the current level of information the most likely root cause of the event are the following: critical failure of the controller leading to a pump stop; presence of clots/thrombus on the impeller/in the upper housing that led to higher current demand from the controller leading to shut down.

Event Description

See initial report.

• Brand Name: ESCORT CONTROLLER
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 11825277
• MDR Text Key: 250628833
• Report Number: 2531527-2021-00018
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K110493
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-8500
• Device Catalogue Number: 5140-8500
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention