MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH PUMP CONTROL PANEL (CP5); CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problems Inaccurate Flow Rate (1249); Unstable (1667)

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

Event Date 05/30/2023

Event Type  malfunction  

Event Description

Livanova deutschland has received a report of a loose knob of cp5 control panel.There is no report of any patient injury.Through follow up, on 05 june 2023, livanova was informed the perfusionist use the flow sensor and did not report any fluctuations in flow or rpms just the loose knob.The perfusionist did not experience any issues during a case but was concerned that the knob being loose would eventually cause problems.The biomed when checking the machine to confirm the loose knob, he reported the fluctuations in flow/rpms.When he would turn the knob to increase or decrease the flow the rpms would not increase or decrease depending on if he was pushing or pulling on the knob when the biomed manipulated the control knob, he felt the knob pull out towards him and push in closer to the panel.As this happened the rpms on both the panel display, the leds and the pump (visually based of disposable, he did not measure with any test equipment) would fluctuate.The biomed reported cp5 control knob was loose and did not accurately control the drive head (pump), that the rpms did not seem to match what was displayed on the control panel.The biomed was concerned about the fluctuations rather than an over or under value of the pump head.

Manufacturer Narrative

A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the pump control panel (cp5).The incident occurred in united states.A livanova field service engineer could not reproduce the claimed issue.The encoder assembly was replaced as a precaution.Encoder assembly was beginning to separate internally, which would have caused the reported problem.Performed all tests and all tests passed.Unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Manufacturer Narrative

H10: a device service history review has been performed and identified that the unit was manufactured in 2014 and no other similar events have been reported.Based on all the collected information, it is reasonable to trace the cause of the event to a loose control knob and the shaft encoder that did not act properly on the rpm (rotation per minute) of the pump.

Event Description

See initial report.

• Brand Name: PUMP CONTROL PANEL (CP5)
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; 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: 17253694
• MDR Text Key: 318581069
• Report Number: 9611109-2023-00296
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K210130
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/23/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1