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

Model Number 10-80-00

Device Problem Unexpected Shutdown (4019)

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

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in newmarket, canada.Pump was not yet made available by the customer in order to carry out testing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.H3 other text : pump not yet made available by the customer.

Event Description

Livanova received report that a s5 roller pump turned off and could not boot during priming.It looks like the on/off switch is defective.There was no patient involvement.

Event Description

See initial report.

Manufacturer Narrative

H10: through a follow-up communication it was learnt that the fault was originally reported incorrectly.It was found that the issue was just related to the display of the pump, which worked intermittently and to the touchscreen was found to be not functional.The led display board with touchscreen was replaced.The unit was then tested without detecting deviations and was put back in service in its expected function.The reported issue is not likely to cause or contribute to death or serious injury since it does not impair the performance of the pump to maintain the blood flow during the cardiac surgery procedure.Moreover, the pump can be still controlled via the speed control knob and alarms can be always displayed on the system panel.Reportability decision has been therefore changed to not reportable event based on the information received.

• 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: 14955311
• MDR Text Key: 295500464
• Report Number: 9611109-2022-00334
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 10-80-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2022
• Initial Date FDA Received: 07/08/2022
• Supplement Dates Manufacturer Received: 07/26/2022
• Supplement Dates FDA Received: 08/24/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/16/2015
• 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