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

Model Number 10-85-00

Device Problem Pumping Stopped (1503)

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

Event Date 02/09/2023

Event Type  malfunction  

Manufacturer Narrative

Patient information were not provided.Livanova deutschland manufactures the s5 double head pump.The incident occurred in sweden.According to follow up, during procedure b-pump suddenly stops with alarm "runaway".Alarm ack and restart of pump solved the problem.Problem occures when the pump speed is rapidly increased or the pump stops when lot of blood is sucked.The pump displayed error message.Medical team elected to switch to another pump in the heart-lung machine to continue the operation.The perfusionist has not used the hand crank when the error occurred the pump was inspected by livanova field service engineer and no problem could be found.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova deutschland has received a report that, during a procedure, the roller pump returned the alarm "runaway".There is no report of any patient injury.

Manufacturer Narrative

H.10.The serial read out (real time device parameters and setting recording file) of the pump was incorrectly collected: read out doesn`t correspond to the pump and pump display shows h0 and not h1 as in the read out.This was identified after clearing the memory (nvmem) so it can no longer be retrieved.The pump has been running for over 48 hours without any problems.Upon investigation, it was found that the message "rc_baditores_fte" appears.Error not confirmed device was cleaned and disinfected, ribbon cables, cable speaker, led display touch screen, pcba hkr board replaced unit returned to customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Manufacturer Narrative

H10: based on the collected information, it was possible to confirm that the pump stop event due to the runaway error was never duplicated by livanova technician.Therefore, as the event only occurred with a rapidly increasing speed, it cannot be excluded that the specific conditions of use led to the complained issue.

Event Description

See initial report.

• Brand Name: S5 DOUBLE HEAD 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: 16512724
• MDR Text Key: 311097184
• Report Number: 9611109-2023-00102
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K071318
• 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
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10-85-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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