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

Catalog Number 10-88-00

Device Problem Failure to Auto Stop (2938)

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

Event Date 10/06/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 mast roller pump, the incident occurred in hannover, germany.Through follow-up communication livanova learned that the issue occurred only once.The arterial pump stopped correctly to level alarms afterwards.Based on provided readout and follow up with the customer: (i) the event occurred on 10 october and not on 11 october however, also on 10 october no event was recorded in the read-out.(ii) the customer correctly connected the level monitoring function to the arterial pump as the level sensor icon appeared on the pump display.However, no error: no monitoring pump was displayed.(iii) the customer realized that monitoring has failed due to audio alarm but pump did not stop.The pump kept spinning even though the level had dropped below the threshold.(iv) sn of the pump involved is 50e01101.(v) the issue was isolated, no other occurrences was observed.(vi) according to latest information, the event occurred at the customer's site on (b)(6) 2022, thus the serial read-out investigation related to this event date is on-going.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland received a report that the arterial pump did not stop to a level alarm during priming.Reportedly, the stop link works on another pump.There was no patient injury.

Event Description

See intial report.

Manufacturer Narrative

A field service engineer was dispatched to the facilitiy.Pump and level sensor modules were checked with level sensor.No error was detected.Test run and functional check without complaint.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

As per follow up with the customer, it was confirmed the event date is (b)(6) 2022.Serial read-out analysis relevant to event date confirmed the reported issue: the level alarm was observed, and no pump rpm zeroing was stored in the arterial pump.The signal to the pump wasn't sent correctly.

Event Description

See intial report.

Manufacturer Narrative

H10: as result of the investigation performed, it cannot be ruled out that the most likely root cause of the reported event could be traced back to the blood level that was borderline and triggered very fast switch level sensor between alarm and no alarm status, not enough to let the pump stop.

Event Description

See initial report.

• Brand Name: S5 MAST 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 80939 ; GM 80939
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 15770166
• MDR Text Key: 305349909
• Report Number: 9611109-2022-00576
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K062396
• 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,Followup
• Report Date: 11/25/2022

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 Catalogue Number: 10-88-00
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/10/2022
• Supplement Dates Manufacturer Received: 10/11/2022; 10/27/2022; 04/26/2023
• Supplement Dates FDA Received: 11/10/2022; 11/25/2022; 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2014
• 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