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

Model Number 25-40-45

Device Problem Device Issue (2379)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/23/2015

Event Type  malfunction  

Manufacturer Narrative

Sorin group (b)(4) manufactures the gas blender.(b)(4).Sorin group (b)(4) received a report that the gas blender displayed an error code.There was no patient involvement.The investigation is on-going.A follow-up report will be sent when the investigation is complete.

Event Description

Sorin group (b)(4) received a report that the gas blender was displaying an error code during set-up.There was no patient involvement.

• Brand Name: S5 GAS BLENDER SYSTEM
• Type of Device: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich, ; GM
• Manufacturer (Section G): SORIN GROUP DEUTSCHLAND; lindberghstr. 25; d 80939 munich, ; GM
• Manufacturer Contact: cheri voorhees ; 14401 west 65th way; arvada, CO 80004
• MDR Report Key: 5092328
• MDR Text Key: 26490412
• Report Number: 9611109-2015-00384
• Device Sequence Number: 1
• Product Code: DTX
• Combination Product (y/n): N
• PMA/PMN Number: K101046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 25-40-45
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/22/2011
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1