MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SRD S5 DOUBLE ROLLER PUMP 85; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report that, during routine preventive maintenance, the s5 double roller pump 85 has a notification error stating 'fault in motor controller (432) pump 2b'.There was no patient involvement.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 double head pump.The incident occurred in malaisia.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: analysis of the read-out of the roller pumps (real-time device parameters and setting recording file) found no data relevant to the event date ((b)(6) 2023).However, log shows the error was displayed on (b)(6) 2023.This error indicates that connector ic12 on hms board does not work and therefore hms and motor are switched off.In log files, also other similar errors are stored before and after the event date.Errors reoccurred until when the service technician replaced the hms board ((b)(6) 2024).A device service history review has been performed and identified that the roller pump was manufactured in 2022 and no other similar events have been received.Based on all the above, it is reasonable to assume that the most likely root cause of the reported event is an early electrical failure of the hms board, likely due to a defective ic12 connector.Failure of electronic boards can be related to multiple and not deterministic factors such as exposure to heat, dust and moisture, accidental impacts (drops and falls), and power overloads/surges but also to variability of micro sub-components.However, there is no concerning trend for this kind of failure.

Event Description

See initial report.

Manufacturer Narrative

Customer reported that the error was constantly showing upon them testing the machine for regular checks.Device was inspected (from third party engineer) and issue confirmed, motor controller (b)(6) was replaced and error message disappeared.Roller pump is working normally.We confirmed that the problem has been solved.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See intial report.

• Brand Name: SRD S5 DOUBLE ROLLER PUMP 85
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• 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: 18500849
• MDR Text Key: 332721789
• Report Number: 9611109-2024-00030
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900405
• UDI-Public: (01)04033817900405(11)221026
• Combination Product (y/n): N
• Reporter Country Code: MY
• 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,Followup
• Report Date: 02/26/2024

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: 10-85-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/13/2023
• Initial Date FDA Received: 01/12/2024
• Supplement Dates Manufacturer Received: 01/31/2024; 03/11/2024
• Supplement Dates FDA Received: 02/27/2024; 04/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/26/2022
• 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