MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 01/23/2023

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6), north carolina.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 a s5 roller pump did not restart when it alarmed; the alarm was not cleared.The issue occurred in procedure.There was no patient injury.

Manufacturer Narrative

H10: through follow-up communication with the customer, livanova learned that it was an operator error and a unit inspection is not required.The issue never came back after training to medical staff.Since the issue was caused by user unintentional error and no issue was caused to the patient, the event has been re-assessed as not reportable.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; 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: 16415960
• MDR Text Key: 310273618
• Report Number: 9611109-2023-00078
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• 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: 02/22/2023

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 Model Number: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/22/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 06/27/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/04/2011
• 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