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

Model Number 10-88-00

Device Problem Pumping Stopped (1503)

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

Event Date 11/02/2021

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.Livanova deutschland manufactures the s5 mast roller pump.The incident occurred in (b)(6).Livanova initiated an investigation and attempted to retrieve information about patient condition.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 a s5 mast roller pump stopped during a procedure in a pediatric operating room and a motor control failure error message was displayed.No additional information was provided regarding the malfunction and patient conditions.No patient injury was reported.

Event Description

See initial report.

Manufacturer Narrative

H.10: through follow-up communication livanova received confirmation that the patient did not reported any injury.The pump was replaced with another and procedure was completed with no further issues.A livanova field service representative was dispatched to the facility and found a piece of tube within the pump raceway.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H.10: the involved mast roller pump was manufactured in 2016 and according to the analysis of the complaints database no similar events have been reported in the past related to this unit.A livanova field service representative was dispatched to the customer facility.The serial read-out of the pump (real time device parameters and setting recording file) was gathered and analyzed: on the day of the event the error message "no_pulse_block" was registered.The registered error code could be due to: the pump occlusion is set too hard; the dimension of the tube set by the user is incorrect; the rotor is blocked by a foreign object.As reported in the previous report, a piece of tube was found in the pump raceway by the livanova field service technician during the visit on site.The involved roller pump was returned to the manufacturer site for investigation.During the intensive test carried out, no deviations were observed.The pump worked within specifications.Based on all the above facts, the most likely root cause of the reported event is the presence of a foreign object (little piece of tube) in the pump raceway, blocking the pump rotor.

• 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 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 12907325
• MDR Text Key: 284629419
• Report Number: 9611109-2021-00685
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K062396
• 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: 11/29/2021

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: 10-88-00
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 01/03/2022; 05/06/2022
• Supplement Dates FDA Received: 01/31/2022; 06/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2014
• 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