MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND SCP FLOW SENSOR 3/8"; CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS

Model Number	96-414-120
Medical Device Problem Code	Inaccurate Flow Rate (1249)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient information was not provided.Livanova (b)(4) manufactures the scp flow sensor 3/8".The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).Through follow-up communication, livanova (b)(4) learned that the user was unable to perform a calibration of the device.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.Device not returned.
Event or Problem Description
Livanova (b)(4) received a report that the scp flow sensor 3/8" displayed a flow rate deviation of -0.9l/min when compared to the actual flow rate during a procedure.The system was rebooted several times and the sensor was disconnected and re-connected, but the issue persisted.The sensor was replaced to continue the procedure.There was no report of patient injury.
Additional Manufacturer Narrative
Livanova (b)(4) manufactures the scp flow sensor 3/8".The incident occurred in (b)(6).The claimed flow sensor was requested back to livanova (b)(4) for investigation.No problem was identified during visual inspection.The sensor was connected to the test bench.The flow rate had -0.9l/min deviation compared with the actual flow rate.The zero point calibration did not work correctly.The system was booted up several times, the extract flow probe was inserted, but the issue persisted.After the replacement with a new flow probe, the problem was removed.A supplier quality notification to the manufacturer of the flow sensor was initiated.A review of the dhr did not identify any deviation or non-conformity relevant to the reported issue.If additional information pertinent to this case will be received, they will be provided in a supplemental report.

• Brand Name: SCP FLOW SENSOR 3/8"
• Common Device Name: CONTROL, PUMP SPEED, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80939 ; GM 80939
• MDR Report Key: 6903652
• Report Number: 9611109-2017-00764
• Device Sequence Number: 10883182
• Product Code: DWA
• UDI-Device Identifier: 04033817901532
• UDI-Public: 04033817901532
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K011838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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
• Operator of Device: Health Professional
• Device Model Number: 96-414-120
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/01/2017
• Supplement Date Received by Manufacturer: 01/14/2018
• Initial Report FDA Received Date: 09/29/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1