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

Model Number 27-80-20-

Device Problem Measurements, inaccurate (1005)

Patient Problem No Patient involvement (2648)

Event Date 11/21/2014

Event Type  malfunction  

Event Description

Sorin group received a report that the pressure displayed by the s5 cardioplegia sensor module pressure was inaccurate during set up.There was no patient involvement.

Manufacturer Narrative

Sorin group (b)(4) manufactures the s5 cardioplegia sensor module.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).The investigation is ongoing.A follow-up report will be sent with the investigation is complete.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 cardioplegia sensor module.The incident occurred in mineola, new york.This medwatch report is being filed on behalf of livanova (b)(4).The livanova field service representative was dispatched to the facility to investigate.The service representative was able to reproduce the issue and observed that the cardioplegia pressure was reading low.The cardioplegia sensor module was replaced and subsequent functional verification testing was completed without further issues.The device was returned to service.The replaced module was returned to livanova (b)(4) for further investigation.The root cause of the described error was confirmed to be a result of poor welding.Two of the pins were found to be welded together.The welding was removed and the module was tested for a 24 hour test run under p-can control with different settings.No further deviations occurred.For saftey reasons, the module was scrapped.A review of the dhr identified that the module failed several automatic test cases that were performed during manufacturing.Upon manual testing, one of the test cases passed when it should have failed.This is the first report for this type of issue.

• Brand Name: S5 CARDIOPLEGIA SENSOR MODULE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; munich D 809 39; GM D 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND; lindberghstr. 25; munich, 80939 ; GM 80939
• Manufacturer Contact: joan ceasar ; 14401 w. 65th way; arvada, CO 80004 ; 2812287260
• MDR Report Key: 4392230
• MDR Text Key: 5437965
• Report Number: 1718850-2014-00480
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27-80-20-
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/21/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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