MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 ROLLER PUMP 150 (S5 RP150); 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 10/23/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that, during periodic service maintenance, livanova was informed that the s5 roller pump 150 displayed again fault in motor controller (e433) as previously reported in 9611109-2023-00408 and 9611109-2023-00626.Livanova service was not successful in duplicating the issue any time.Several components have been replaced and customer reported the issue has occurred a third time.Livanova has been informed the medical team switched the pump assignment from cardioplegia to sucker and that since switching they have not had that issue and no further alarm.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump 150.The incident occurred in usa.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: claimed error code reported, can be caused by: occlusion set too strong (user error) or wrong tubing used by the customer (user error) or rotor blocked by a foreign object or defective bearing or defective motor controller board (hms).Field service technician dispatched on-site for the third time was not able to reproduce the issue.The claimed pump was extensively tested without showing any hardware failure.No additional replacement has been performed since the last activity was done two months earlier.Complaint database analysis revealed no concerning trend for this type of failure.Considering the information provided by the livanova field service representative who tested the pump, a mechanical problem with the pump has been ruled out to be a contributing factor to the event.Based on the collected information and considering that issue was solved by changing the role of the pump, it is reasonable to assume that the customer faced a motor control failure caused by a pump occlusion being set too high or by a wrong tubing size.Both possible root causes might have been solved after the pump role change since different tubes could have been required.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 18500788
• MDR Text Key: 333125899
• Report Number: 9611109-2024-00028
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180323
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-80-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• 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