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

Model Number 10-80-00

Device Problem Failure to Auto Stop (2938)

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

Event Date 03/29/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Software was re-installed on the pumps.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a s5 roller pump did not stop during priming when the main pump stopped even if the stop link function was activated.Reportedly, the customer realized it since the pressure of oxygenator became negative.The customer re-started priming and no problem was found.Surgery completed without problems.After surgery, the customer requested a check of the device just as precaution.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H.10: complaints database analysis revealed no similar event since unit installation in 2013 and no further complaints regarding this issue on this machine have been reported up to date.Therefore, it is reasonably to assume that the issue did not recur.The reported issue could be caused by: master pump turned off after stop-link function activated, can connector of master pump broken, can bus interruption (broken wiring or emc disturbance), an hardware failure, such as broken master pump can connector as well as broken wiring, can be excluded from the possible root causes based on the fact that the issue did not recur and the machine passed all functional tests successfully and is fully functional at the customer site.Thus, based on the available information, it cannot be ruled out that emc disturbances or master pump being turned off after stop-link function activated may have led to reported issue.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 14220115
• MDR Text Key: 290284341
• Report Number: 9611109-2022-00194
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 04/26/2022

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: 03/30/2022
• Initial Date FDA Received: 04/27/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/20/2013
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1