MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S3 BUBB DET SENSOR, LOW LEVEL II; MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS

Model Number 23-27-40

Device Problem Failure to Sense (1559)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/31/2020

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the x.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility and could confirm the reported issue.He found out that the level sensor was defective.He replaced the device and the problem was solved.Subsequent functional verification testing was completed without further issues and the unit was returned to service.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 that the level sensor did not alarm during a procedure.The level sensor was swapped out with another one and the procedure could be completed without further issues.There was no report of patient injury.

Event Description

See initial report.

Manufacturer Narrative

H.10: the serial read out of the pump was analysed and it was noticed a mismatch between the event date provided by the customer and the dates in the serial read-out.If the correct event date is the one present in the pump serial read-out (b)(6) 2020) instead of (b)(6) 2020, it can be assumed that the sensor was tested before starting the procedure as per the instruction for use.Further information will not be provided due to covid-19 emergency.If any additional information is provided, it will be provided in a supplemental report.

• Brand Name: S3 BUBB DET SENSOR, LOW LEVEL II
• Type of Device: MONITOR AND/OR CONTROL, LEVEL SENSING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9785566
• MDR Text Key: 197123874
• Report Number: 9611109-2020-00158
• Device Sequence Number: 1
• Product Code: DTW
• Combination Product (y/n): N
• 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: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 23-27-40
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1