MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH ESSENZ HLM - ROLLER PD85; 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 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the essenz hlm pump.The incident occurred in united states.A 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 deutschland received a report that, during a procedure on the second dose of cardioplegia delivery, when the perfusionist turned the knob to start the pump, the error alarm "cpl-b pump defective 2329 was displayed together with orange box and a wrench symbol.According to perfusionist, pump did not run, the perfusionist tried gain and the pump worked.There is no report of any patient injury.

Manufacturer Narrative

H10: based on software code inspection, reported error code 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.

Event Description

See initial report.

• Brand Name: ESSENZ HLM - ROLLER PD85
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 18273516
• MDR Text Key: 329825906
• Report Number: 9611109-2023-00616
• Device Sequence Number: 1
• Product Code: DTQ
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 02/13/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/21/2023
• 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