MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH SENSOR MODULE FOR S3 DPC; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 22-10-20

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Serial number is unknown.This information will be provided in a supplemental report if made available.As the serial number is unknown, the device manufacture date could not be determined.This information will be provided in a supplemental report if made available.Livanova (b)(4) manufactures the sensor module for s3 dpc.The incident occurred in (b)(6).Livanova (b)(4) initiated an investigation.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 10 minutes after starting the procedure, an error message occurred on the pressure sensor module.The user cleared the alarm and after 5 minutes the issue re-occurred multiple times.The user restarted the s5 system power supply, the initial setting were no longer there and dashes were displayed.There was no report of patient injury.

Manufacturer Narrative

H.10: the issue could not be reproduced by the livanova representative.However, the engineer performed a memory clear and returned the device back to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.

Event Description

See initial report.

Event Description

See initial report.

Manufacturer Narrative

H.10: the information received on 21.Jan.2020 triggered a reportability decision change for the event which has been assessed as non-reportable due to confirmation that the reported issue was actually related to the pressure sensor thus, the monitorning/control functions of the pump were not affected by any malfunction.Indeed, a malfunction of the pressure sensor is not likely to contribute to death or serious injury since it has no impact on the functionality of the pump and it is always detectable prior to patient involvement.

• Brand Name: SENSOR MODULE FOR S3 DPC
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich
• MDR Report Key: 9443052
• MDR Text Key: 194320890
• Report Number: 9611109-2019-00956
• Device Sequence Number: 1
• Product Code: DWB
• Combination Product (y/n): N
• PMA/PMN Number: K950990
• 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,Followup
• Report Date: 02/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 22-10-20
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1