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

Model Number 10-80-00

Device Problem Contamination (1120)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that during priming tubing came apart after raceway rupture into s5 roller pump.There was no patient involvement.

Manufacturer Narrative

Pt.Info: there was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: complaints database analysis revealed that no similar event on this device occurred since its installation in 2018.Through follow-up communication, livanova retrieved the following information: - the customer was using a livanova disposable pack, - the hardware components were in a good state and are unlikely to have solely caused the issue.Based on all the above facts, the case can be considered an isolated event and it cannot be ruled out that an excessive over-occlusion of the roller pump may have led to the tubing rupture and, consequently, the blood leak.

Event Description

See initial report.

Manufacturer Narrative

A livanova field service engineer was dispatched to the customer to investigate the device.The roller pump was verified, the raceway was good and was not out of round, no sharp edges or anything that would cut tubing was identified during inspection and cleaning.The raceway, the roller pump heads, rollers, and tube guides were cleaned.The machine passed all check and tests and returned to service.The hardware was good and no definite conclusion could be drawn as to what exactly happened.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 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: 16032331
• MDR Text Key: 308373234
• Report Number: 9611109-2022-00684
• 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,Followup
• Report Date: 01/18/2023

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: 11/28/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 12/23/2022; 02/28/2023
• Supplement Dates FDA Received: 01/19/2023; 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2018
• 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