MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number 60-01-00

Device Problems Decreased Pump Speed (1500); Vibration (1674)

Patient Problem Hemolysis (1886)

Event Date 09/24/2020

Event Type  Injury  

Manufacturer Narrative

Patient information was not provided.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).A field service technician was dispatched to the facility to investigate the device.No deviations or defects could be identified.Investigation is ongoing.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova received report of hemolysis observed in laboratory test results and dark colored urine.The patient had been under ecmo support with a centrifugal pump system approximately for 36 hours.The drive unit was noisy and vibrating.Reportedly, above 2000 rpms, the blood flow decreased even if the pump speed was the same.The user replaced the drive unit and used the same disposables kit on the back-up unit.Above 3000 rpms, vibrations occurred also with the second device.However, they were smaller and support continued and is still on.After drive unit replacement, reduction of hemolysis and no macroscopic hemolysis were observed.The patient required blood transfusion and respirator therapy including oxygen concentration in the breathing mixture 100% and peep > 25.

Event Description

See initial report.

Manufacturer Narrative

H.10: a review of the dhr could not identify any deviations or nonconformities relevant to the issue.The drive unit was requested for a further investigation: no vibrations and noise were detected during the functional test.A technical safety inspection was successfully carried out and the unit will be shipped back to the customer in its expected function.Taking into account that the same revolution was mounted on the second drive unit used by the customer to continue the support, it cannot be ruled out that an incorrect positioning of the revolution disposable pump on the drive unit have led to the reported vibrations and noise.According to the instruction for use of the scp system (cp_ifu_60-00-00), it is indicated that the retaining key of the drive unit must hold in place.If not, the revolution pump is not stable on the blue cover of the drive unit, leading to noise and vibrations.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

H.10: based on the fact that no equipment defect could be found and it worked within specifications, the centrifugal pump system can be excluded from being a potential root cause of the reported event.Therefore, the event has been re-assessed as non reportable.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 11051036
• MDR Text Key: 223181366
• Report Number: 9611109-2020-00699
• Device Sequence Number: 1
• Product Code: DWA
• Combination Product (y/n): N
• PMA/PMN Number: K032213
• 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,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60-01-00
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention