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

Model Number 60-02-15

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/25/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).The reported issue could be confirmed through provided videos.A livanova field service representative was dispatched to the facility to investigate and found that the mounting nut of the knob was loose causing the reported failure.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

Livanova (b)(4) received a report of a centrifugal pump system with tubing clamp with the speed control knob which could not be rotated during use.There was no report of patient injury.

Manufacturer Narrative

H.10: a review of the dhr could not identify any deviations or non conformities relevant to the issue.The knob nut was found to be loose and the technician re-tightened it in order to solve the problem.Subsequently functional tests were preformed and passed and the unit was returned to regular service.

Event Description

See initial 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
• MDR Report Key: 11242915
• MDR Text Key: 240342299
• Report Number: 9611109-2021-00048
• 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: 01/25/2021

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: 60-02-15
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/29/2020
• Initial Date FDA Received: 01/28/2021
• Supplement Dates Manufacturer Received: 02/02/2021
• Supplement Dates FDA Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1