MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP 5 (CP5); CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-02-60

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 08/19/2021

Event Type  Injury  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.A preliminary analysis based on currently available information suggests that the reported interruption of bypass was not related to the incorrect readings of the flow sensor.In this situation the user could have replaced the flow sensor or restarted the hlm while on bypass.Investigation is in progress.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(6) received a report that a centrifugal pump 5 (cp5) displayed negative flow values (-3.5 and -5 lpm) during bypass.However, the flow was confirmed to be forward through arterial line.Decision was taken to come off of bypass.The complete hlm was restarted and the issue improved.The patient is doing well.

Event Description

See initial report.

Manufacturer Narrative

H.10: manufacturing records were verified and no deviations or non-conformities relevant to the reported issues were identified.A livanova field service representative was dispatched to the facility to check the system.No deviation was identified during the technical safety inspection, thus excluding hardware failures on the entire system.Analysis of the serial read-out of all the involved pumps has been performed and revealed that a reset event was stored in the microcontroller of all the units listed above.Cause of these type of events can be related to hardware failures or to external causes, such as interferences from high frequency devices, which can affect the flow measurement.Based on the above facts, it is very unlikely that a hardware fault occurs in all the pumps of the console simultaneously.Indeed, all the pumps were tested and found to be working within specifications.Thus, the most likely root cause of the reported event was traced back to external interferences from high frequency devices leading to a simultaneous reset event on all pumps and to flow measurement issues.As per device instruction for use , it is strongly recommended to check the operating theatre and the ambient of the operating theatre for emissions of high frequency emitting devices and to always have connected the potential equalization cable to earth.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich
• MDR Report Key: 12487868
• MDR Text Key: 271892026
• Report Number: 9611109-2021-00518
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K112225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-02-60
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other