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 08/14/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in seoul, south korea.The involved pump ran normally during first delivery of cold cardioplegic solution during surgery and it continued to run normally even when warm cardioplegic solution was delivered 90 minutes later.However, the pump suddenly stopped with an error message when warm cardioplegic solution was delivered again, 3 minutes later.The pump is being utilized by the customer for both the 1/4" tubing line and the 1/8" tubing line with blood cardioplegia simultaneously.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, used as cardioplegia one, stopped and gave a motor control failure error message.The issue occurred during procedure.There was no patient injury.

Event Description

See initial report.

Manufacturer Narrative

Visual inspection of the complained pump found residue in pump raceway that were then removed.Raceway intact, no obvious malfunction of the bearing.Functional check performed.Serial readout and clear nvmem performed.The error code 442 indicates a detection of a set speed value different to actual value and can be due to: 1 occlusion too hard, 2 wrong tubing, 3 rotor blocked by foreign object or 4 rotor tight rotating -> bearing defective.Since per tssi activity the root cause 4 is excluded, the three remaining root causes (1, 2 and 3) are ascribable to user set up or user error, for this reason the event has been re-evaluated as not reportable.

• 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 GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17754371
• MDR Text Key: 323472042
• Report Number: 9611109-2023-00443
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)220617
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2023
• 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
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2022
• 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