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

Model Number	10-80-00Z
Medical Device Problem Code	Failure to Auto Stop (2938)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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.
Additional 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 or Problem Description
See initial report.

• Brand Name: S5 ROLLER PUMP
• Common Device Name: 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
• Report Number: 9611109-2022-00325
• Device Sequence Number: 4534865
• Product Code: DWB
• UDI-Device Identifier: 04033817902713
• UDI-Public: (01)04033817902713(11)211206
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 10-80-00Z
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 07/07/2022
• Supplement Report FDA Received Date: 11/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown