MAUDE Adverse Event Report: SORIN GROUP DEUTSCHLAND S5 GAS BLENDER SYSTEM; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number 25-40-45

Device Problem Other (for use when an appropriate device code cannot be identified) (2203)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

Sorin group (b)(4) received a report that s5 gas blender system momentarily switched on then off during a procedure.The clinician later found that the power cable was loose.Once tightened, no other issues occurred.There was no patient injury.

Manufacturer Narrative

Patient information was not provided.Sorin group (b)(4) manufactures the s5 gas blender system.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the s5 gas blender system momentarily switched on then off during a procedure.The clinician later found that the power cable was loose.Once tightened, no other issues occurred.There was no patient injury.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.See scanned page.

Manufacturer Narrative

Livanova (b)(4) manufactures the s5 gas blender system.The event occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The customer performed self-service by tightening the can connection of the gas blender.The unit was run for a few hours and reportedly worked within specifications.Additionally, a service representative was dispatched to the facility to analyze the unit.The service representative was unable to reproduce the issue and the unit worked within specifications.The device was returned to service.The loose can connection was determined to be the root cause of the reported issue.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, 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: 4763356
• MDR Text Key: 5787970
• Report Number: 9611109-2015-00131
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Unknown
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2012
• 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