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

Model Number 10-80-00Z

Device Problem Failure to Auto Stop (2938)

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

Event Date 05/02/2022

Event Type  malfunction  

Event Description

Livanova deutschland received a report that a s5 roller pump had intermittent creep when set at 0.00 lpm/0 rpm.There was no report if patient injury.

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in cork, ireland.Through follow-up communication livanova learned that the reported issue occurred on this specific pump only and no error messages were displayed on the pump.In addition, it was learned that the bip sound was not audible when the speed control knob was set to zero since it was not set previously.Once the setting is activated, the bip sound is audible when the knob is set to zero.Furthermore, it was found that the leds around the knob are not exactly at zero when the pump creep occurs.Indeed, when the issue occurs the light is on the second led and not to zero.Investigation is still ongoing.A replacement device will be provided to the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

According to the pump expected behavior, the rpms are exactly set to zero when the the leds around the knob are exactly at zero and the bip sound is audible.Through further follow up communication, it was learned that the involved pump is currently in use at the customer site and that the issue did not recur.No component replacement was carried out and the pump is functional.Taking into account collected information, hardware malfunctions of the pump can be ruled out as cause of the event.It is very likely that the rpms of the pump were not actually set to zero when the pump creep was detected by the user.

Event Description

See initial report.

• 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: 14942549
• MDR Text Key: 295501033
• Report Number: 9611109-2022-00325
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)211206
• Combination Product (y/n): N
• Reporter Country Code: EI
• 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: 07/07/2022

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: 10-80-00Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2022
• Initial Date FDA Received: 07/07/2022
• Supplement Dates Manufacturer Received: 10/05/2022
• Supplement Dates FDA Received: 11/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• 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