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

Catalog Number 60-03-75

Device Problem Pumping Stopped (1503)

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

Event Date 10/17/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.Patient information was not provided.The event is related to a pump stop.H10: livanova deutschland manufactures the scpc centrifugal pump console.The incident occurred in germany.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 a centrifugal pump console stopped during use and the emergency drive unit was used.There was no patient injury.

Event Description

Initial report.

Manufacturer Narrative

Thought follow up from the customer, livanova was informed that, when the scpc has stopped, the screen frozen on the control panel, no error code was displayed and it had to be cranked.Device is not being used.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: CENTRIFUGAL PUMP CONSOLE
• 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: 18139482
• MDR Text Key: 328155877
• Report Number: 9611109-2023-00606
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K020571
• 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: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 60-03-75
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/18/2023
• Initial Date FDA Received: 11/15/2023
• Supplement Dates Manufacturer Received: 02/01/2024
• Supplement Dates FDA Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/30/2012
• 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