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

Model Number	60-02-15
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There was no patient involvement.Livanova deutschland manufactures the centrifugal pump system with tubing clamp.The event occurred in (b)(6).Through follow-up communication with the customer, livanova deutschland learned that the pump speed could not be properly controlled by the shaft angle encoder and a video had been provided as evidence of the reported malfunction.A livanova field service representative was dispatched to the facility to investigate and could confirm the reported issue.He temporarily replaced the control panel with another one provided by the customer to fix the issue.A review of the dhr could not identify any deviations or nonconformities relevant to the issue.However, livanova deutschland requested the device back for further investigations.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova deutschland received a report that the control knob of a centrifugal pump system with tubing clamp was grinding while turning.The event occurred during training.There was no patient involvement.
Additional Manufacturer Narrative
H.10: the device was requested back to livanova deutschland for further investigation.The reported issue could be reproduced: it was not possible to turn the encoder, the shaft was completely stuck.The cause of the reported event has been identified in a defective shaft angle encoder.

• 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: 8353690
• Report Number: 9611109-2019-00097
• Device Sequence Number: 2120241
• Product Code: DWA
• UDI-Device Identifier: 04033817900986
• UDI-Public: (01)04033817900986(11)181024
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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): 04/23/2019

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: 60-02-15
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/25/2019
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 02/20/2019
• Supplement Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1