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

Model Number	60-01-00
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Noise, Audible (3273)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Date of event was not provided.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).The centrifugal pump was returned to livanova (b)(4) for further investigation.During the evaluation the reported issue could be confirmed.During the visual investigation, metal particles which broke off the rotor could be detected.These could be determined as root cause for the reported issue.A specific root cause how the mechanical damage occurred could not be determined.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
Event or Problem Description
Livanova (b)(4) received a report that a centrifugal pump system with tubing clamp displayed an error message and was noisy during set up.There was no patient involvement.
Additional Manufacturer Narrative
Further investigation on the returned device revealed that the root cause of the reported error message was a loose contact in the supply cable of the centrifuge drive unit.
Event or Problem Description
See initial.

• Brand Name: CENTRIFUGAL PUMP SYSTEM WITH TUBING CLAMP
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8339141
• Report Number: 9611109-2019-00076
• Device Sequence Number: 11209818
• Product Code: DWA
• UDI-Device Identifier: 04033817900931
• UDI-Public: (01)04033817900931(11)180806
• Combination Product (Y/N): N
• PMA/510(K) Number: K032213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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
• Operator of Device: Health Professional
• Device Model Number: 60-01-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/18/2019
• Supplement Date Received by Manufacturer: 02/28/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1