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

Model Number UNKNOWN

Device Problem Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/09/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was not provided.The model number and the serial number have not been provided.This information will be provided in a follow-up report, if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a follow-up report if made available.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Device not returned.

Event Description

On (b)(6) 2017, livanova (b)(4) received a user medwatch report (mw5073384) stating that a centrifugal pump system with tubing clamp was not working properly during a procedure.The perfusionist believed the problem was with the impeller head.The evaluation by the biomedical technician indicated that the cable coming from the control panel and going into the drive unit had been pulled out the strain relief of the drive unit.Also some connection inside the drive unit had been pulled up.They were all still making a connection but were not seated properly.There was no report of patient injury.

Manufacturer Narrative

Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.Follow-up to retrieve the required information was unable to be performed as there is no hospital, device or patient information made available.Therefore a review of the dhr could not be performed nor could a root cause be determined.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Type of Device: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 7157896
• MDR Text Key: 96237482
• Report Number: 9611109-2018-00010
• 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
• Report Date: 02/19/2018

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: UNKNOWN
• Initial Date Manufacturer Received: 12/07/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 02/19/2018
• Supplement Dates FDA Received: 02/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1