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

Model Number 5140-8500

Device Problems Fluid/Blood Leak (1250); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2021

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.(b)(4).Livanova initiated an investigation.Through follow-up communication livanova learned that the reported issue occurred twice in an 18 hours time period.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report that fluid was noticed dripping out the infusate line used on a tandemheart escort controller.The infusate line was then found collapsed and therefore replaced but the issue re-occurred two hours later thus the user decided to replace the controller.Patient is still under support.There was no report of patient injury.

Manufacturer Narrative

H.10: a visual inspection on the claimed escort controller was performed.Fluid residue was noted on the outside of the controller.The infusion pump was inspected.There were no signs of damage.The infusion pump doors were verified to be opening and closing properly without any binding.Based on the facts above and considering the provided picture from the field, it cannot be ruled out that the most likely root cause of the reported event is an incorrect positioning of the infusate line which led to the line damage.

Event Description

See initial report.

• Brand Name: TANDEMHEART ESCORT CONTROLLER
• Type of Device: NON-ROLLER TYPE BLOOD PUMP
• Manufacturer (Section D): CARDIACASSIST INC.; 620 alpha drive; pittsburgh PA 15238
• MDR Report Key: 11391585
• MDR Text Key: 244889649
• Report Number: 2531527-2021-00012
• 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: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5140-8500
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1