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

Model Number 10-80-00

Device Problem Pumping Stopped (1503)

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

Event Date 06/17/2022

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova deutschland manufactures the s5 roller pump.The incident occurred in london, united kingdom.Through follow-up communication livanova learned that the machine was replaced to continue the procedure.Customer reported that he could not see any alarm/error message when the failure occurred.It was communicated that even if the pump worked later on, decision was made to take the machine out of service.Customer reported that no alarm was seen when the failure occurred, however in the original event description it was stated that user hand-cranked the pump until all alarms were silenced.It is unclear if alarms were displayed or not.In addition, the customer communicated that the pump failure happened, it was around 15:05.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.Subsequent functional verification testing was completed without further issues.Serial read-out of the pump have requested and will be analysed.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report that a s5 roller pump stopped during bypass.The user hand-cranked the pump until all alarms where silenced and issue passed with no re-occurrence.Possible tubing issue forcing the pump cover up and stopping the pump during operation and possible user error were reported.There was no patient injury.

Manufacturer Narrative

Livanova received report that a s5 roller pump stopped during bypass.There was no patient injury.Unit was investigated and issue could not be reproduced.The complained unit was returned to manufacturer.The missing nylon washer was replaced.The screw and snap ring were found loose in the housing functionally tests were succefull and unit is returned to customer.According to complaints database review, no further similar issue has been submitted for this unit since its installation in 2015.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See intial report.

Manufacturer Narrative

H10: the serial read-out of the pump (real time device parameters and setting recording file) was analyzed and no deviations related to hardware or software were identified.The analysis revealed that three (3) cover alarm occurred before performing the hand crank.The pump was requested for a dedicated investigation and undergone a six hours test with the pump running at maximum allowed speed.No deviations were observed during the entire test, the pump never stopped and no alarms / error messages have been displayed on the s5 control display module.The serial read out of the pump was analyzed again confirming no issues during testing.According to complaints database review, no further similar issue has been submitted for this unit since its installation in 2015.Based on above facts and considering that no deviations were found during service inspection and testing activity, it cannot be ruled out that the most likely root cause of the reported event is traced back to a tubing issue due to an incorrect pump occlusion set 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: 15025914
• MDR Text Key: 295966234
• Report Number: 9611109-2022-00341
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)150824
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2022
• 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
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2015
• 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