MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND S5 ROLLER PUMP 150 (S5 RP150); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 10-80-00

Device Problem Decreased Pump Speed (1500)

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

Event Date 07/04/2023

Event Type  malfunction  

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6), germany.During maintenance and repair activity done by a livanova field service representative, in addition to encoder replacement, s5 system was flashed to a new firmware (r324).Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 rotary encoder of a s5 roller pump was replaced during maintenance activity since it gave an error message (error setpoint encoder).It cannot be excluded that pump speed was not adjustable.There was no patient involvement.

Manufacturer Narrative

As per follow-up communication, error message "shaft angle encoder fault pump 8" was displayed.It signals that the pump speed can no longer be adjusted correctly.As troubleshooting the shaft encoder (#96-414-506) was replaced.Functional test passed positively and unit was returned to service.Complaint database review revealed that unit was installed in 2018 and no further similar issues are reported.Based on the outcome of service activity, it cannot be ruled out that the most likely root cause of the reported event is a defective shaft encoder.The risk is in the acceptable region.No specific action was currently deemed necessary.Livanova will keep monitoring the market.

Event Description

See initial report.

• Brand Name: S5 ROLLER PUMP 150 (S5 RP150)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 17441053
• MDR Text Key: 320219439
• Report Number: 9611109-2023-00373
• Device Sequence Number: 1
• Product Code: DWB
• UDI-Device Identifier: 04033817900382
• UDI-Public: (01)04033817900382(11)180208
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 09/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• 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: 08/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/08/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Reuse
• Patient Sequence Number: 1