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

Model Number 10-80-00

Device Problems Pumping Stopped (1503); Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 roller pump.The incident occurred in (b)(6).A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.Through follow-up communication livanova learned that the s5 system had completely shutted down without switching over to the batteries.The perfusionist turned on the pump and it was not working.A livanova field service representative was dispatched to the facility to investigate the device and could not confirm the reported issue.The machine was found to be working within specification.Functional verification testing was completed without further issues and the unit was returned to service.Through follow-up communication livanova learned that there was a problem with the emergency electrical network in the operating room with a frequency change which led several equipment at fault.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report that an arterial pump stopped during procedure.The perfusionist hand-cranked the pump and then replaced it with a back up device.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: the serial read-out of the pump has been analyzed and confirmed the reported event since can interruption error messages were stored into the microcontroller indicating an internal connection failure.Thus, the affected pump was requested back for a detailed investigation.Investigation results revealed that the device was working properly and no deviations could be identified.Through further follow-up communication livanova learned that the hospital had problems with the main power supply.Following to that, the emergency network took over the power supply of the device.However, also the emergency network failed generating a frequency which exceeded the tolerances of the machine and causing it to shut down (reportedly, this problem led several equipment at fault).In this case the switch mode power supply of the hlm could not guarantee the required system voltage thus, it was expected to generate a signal in order to switch on batteries (ups mode) but this did not happen.There are two possible causes for this type of issue: 1) it is likely the hlm had already ran in ups mode for a long time when the first problem occurred with the main power supply.Therefore, it is possible that the batteries were completely discharged when the second problem with the emergency network of the hospital occurred.This information doesn't remain stored in the hlm memory and based on current level of information it cannot be confirmed.2) electromagnetic compatibility (emc) problem is also a potential root cause of the reported issue since an unstable mains power could lead to very high conducted disturbances.The interferences may cause internal malfunctions of the hlm.Based on the fact that the field service technician tested the machine and it was found to perfectly run on battery and on the fact that reportedly the frequency generated by the hospital emergency network led several equipment at fault, the most likely root cause of the event was an emc issue due to external devices.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: S5 ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9664191
• MDR Text Key: 196434022
• Report Number: 9611109-2020-00046
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/06/2020
• Initial Date FDA Received: 02/04/2020
• Supplement Dates Manufacturer Received: 03/10/2020
• Supplement Dates FDA Received: 04/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1