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

Model Number 5140-8500

Device Problem Pumping Stopped (1503)

Patient Problem Cardiac Arrest (1762)

Event Date 03/21/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Cardiacassist inc.Manufactures the escort controller.The incident occurred in (b)(6).The product involved was returned for evaluation.The site did not provide the serial number of the pump or controller in this incident even if requested.A controller data log file was provided, but the site was unable to confirm that this data log was from the controller used in this case.The provided data log file showed activity, including a pump stop, at 02:35 on (b)(6) 2021.In the minutes prior to the pump stopping, current increased significantly, with no change in speed or measured flow.An increase in current indicates increased load on the motor.Since neither the speed nor the flow increases along with the current, it is likely that this increased load is due to increased mechanical resistance in the pump.This can be caused by clot or thrombus formation or by introduction of air into the lower housing of the pump due to improper priming or improper maintenance of the infusion system used to maintain the fluid bearing in the pump lower housing.A review of the data log showed no disturbances in the infusion flow in the hours prior to the pump stop.The controller is designed to operate the pump at a fixed speed set by the operator and to supply the needed motor current to maintain the set speed.Typical current demand at 7500 rpm is in the range of 1.20a-1.40a depending on cannulation.The controller can supply up to 1.8a with short duration peaks exceeding this.The data just prior to the pump stop is consistent with the current needed to operate the motor at the set speed exceeding the maximum which the controller is capable to provide.The final data log entry prior to the pump stop showed a pump speed of 6867 rpm and a current of 2.24a.The controller operated as designed in this scenario by switching to the internal backup motor controller and attempting to restart the pump.The internal backup controller was also unable to start the pump.The data log file provided contains data which is consistent with a pump failure.This can occur due to clot or thrombus formation in the pump, but the specific cause remains unknown since the site did not return the pump for evaluation.Based on the data log file, the controller operated within specification and may continue to be used.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 escort controller stopped working at 02:00, the pump stopped during support and reportedly, the patient went into cardiac arrest within three minutes.The circuit was replaced with lifesparc system and support could be restarted.The patient was already on the ventilator prior to the event and medications were given during the pump stop to support the patient until support was re-established.

• Brand Name: ESCORT CONTROLLER
• 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: enrico greco ; 620 alpha drive; pittsburgh, PA 15238
• MDR Report Key: 11899611
• MDR Text Key: 266274416
• Report Number: 2531527-2021-00021
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-8500
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/21/2021
• Initial Date FDA Received: 05/28/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention