MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SORIN S5 SYSTEM; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number	48-30-00
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Further details on patient information were not provided.Livanova (b)(4) manufactures the sorin s5 system.The incident occurred in nashville, united states.A livanova field service representative was dispatched to the facility to investigate.The service representative was able to confirm the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
Event or Problem Description
Livanova (b)(4) received a report that a sorin s5 system did not display flow values during procedure.There was no report of patient injury.
Additional Manufacturer Narrative
H.10: the flow probe and then the scp control panel were replaced and the issue was still present.It was reported that the customer was using a customer-made tubing set with 1/4" x 3/16" segment for use with 1/4" flow probe.The flow probe must only be used with a pvc tubing with a diameter of 3/8" x 3/32" as per the instruction for use.Based on the above, the root cause of the reported malfunction could be traced back to a failure to follow the instruction for use.
Event or Problem Description
See initial report.

• Brand Name: SORIN S5 SYSTEM
• Common Device Name: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich
• MDR Report Key: 8721192
• Report Number: 9611109-2019-00465
• Device Sequence Number: 19279529
• Product Code: DTQ
• UDI-Device Identifier: 04033817900887
• UDI-Public: 010403381790088711180530
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K071318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2020

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: 48-30-00
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/22/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 06/21/2019
• Supplement Report FDA Received Date: 01/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 3