MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SMALL ESSENZ ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-95-00

Device Problem Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/08/2023

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a small essenz roller pump gave an error message related to pump defective, as soon as cardioplegia was started, following turning the knob.The pump now is working properly with no issues.There was no patient injury.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the small essenz roller pump.The incident occurred in medina, saudi arabia.Error message occurred (code number 2329) is related to motor control board of the pump drive and it could be related to over occlusion, wrong direction of rotation, hand cranking or blocked rotor through foreign object.A livanova field service representative was dispatched to the facility to investigate the device: over-occlusion was checked and there was no issue.In addition, through follow-up communication livanova learned that the pump remained totally functional.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

Based on software code inspection, alarm 2329 can potentially lead to a pump stop disabling the pump restarts only in case of a mechanical block.In such case, the issue can always be detectable by the user.Indeed, the pump cannot be restarted by turning the knob, but only by removing the mechanical blockage (e.G.Over occlusion or foreign materials).Based on this, the event is being reassessed as not reportable since it has unlikely possibility to cause any patient injury.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: SMALL ESSENZ ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18273517
• MDR Text Key: 329825890
• Report Number: 9611109-2023-00617
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K232291
• 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,Followup
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-95-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/16/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/08/2023
• 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