MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH RPD150; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Catalog Number 10-90-00

Device Problem Pumping Stopped (1503)

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

Event Date 11/14/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.H10: livanova deutschland manufactures the essenza pump.The incident occurred in the netherland.Pump can be used since this error is resolved.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 prcedure, the essenza rpd150 pump displayed error indicating deviation of the observed direction of rotation from the set direction of rotation (e2350) and stopped.After turning the knob to zero (0) and back to initial flow the pump started again.Procedure could be finished.There is no report of any patient injury.

Manufacturer Narrative

The involved pump is a left vent pump connected to cu.Log provided and found to be empty.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: RPD150
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18309614
• MDR Text Key: 330262610
• Report Number: 9611109-2023-00634
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 04033817902997
• UDI-Public: 010403381790299711230220
• 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,Followup
• Report Date: 12/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10-90-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/20/2023
• 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