MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND GMBH S5 CARDIOPLEGIA SENSOR MODULE; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 27-80-20

Device Problem Failure to Auto Stop (2938)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

There was no patient involvement.Livanova (b)(4) manufactures the s5 cardioplegia sensor module.The incident occurred in (b)(6).A livanova field service representative was dispatched to the facility to investigate the device and the issue could not be duplicated.The device will be replaced with a loaner.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 Description

Livanova (b)(4) received a report that a s5 cardioplegia sensor module probably failed during setup.The used noticed that the cardioplegia pump was off thus, it was turned on in the middle.The delivery of cardioplegia solution was started but the cardioplegia pump did not stop when the set amount of cardioplegia solution was delivered.Moreover, the total volume count did not appear on the display.There was no patient involvement.

• Brand Name: S5 CARDIOPLEGIA SENSOR MODULE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND GMBH; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich 80309 ; GM 80309
• Manufacturer Contact: enrico greco ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 9316353
• MDR Text Key: 196428682
• Report Number: 9611109-2019-00895
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27-80-20
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/17/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1