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

Model Number 60-02-60

Device Problem Infusion or Flow Problem (2964)

Patient Problems Low Oxygen Saturation (2477); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/30/2021

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump 5 (cp5).The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received a report about pump flow decreased to 1000 and flow not possible to restart.Pump stopped by user and hand crank started.Patient hemodynamically and oxygenation recovered before transfer to another machine.

Manufacturer Narrative

H.10: through follow-up communication livanova learned that the patient was not injured and that the procedure could be completed successfully thus section b.1 has been updated accordingly as malfunction and health effect - impact code/health effect - clinical code have been updated as well since no impact on patient was reported.A livanova field service representative was dispatched to the facility to investigate the device and could not reproduce the reported issue.All s5 system and cp5 were found to be working within specifications and no deviation could be identified.Serial read out analysis of the pump revealed an error message associated with a failure in the speed detection of the drive unit on the date of the event.Based on the available information, the most likely root cause of the reported issue is an intermittent failure of the motor control board in the speed detection of drive unit.The part will be replaced to solve the reported issue.

Event Description

See initial report.

• Brand Name: CENTRIFUGAL PUMP 5 (CP5)
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 13116784
• MDR Text Key: 282956870
• Report Number: 1718850-2021-01224
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 60-02-60
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/04/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 03/01/2022
• Supplement Dates FDA Received: 03/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 11 YR
• Patient Sex: Female
• Patient Weight: 40 KG