MAUDE Adverse Event Report: SORIN GROUP USA HEART-LUNG MACHINE

Model Number S5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abnormal Blood Gases (1034)

Event Date 05/09/2017

Event Type  Injury  

Event Description

High pco2 levels noted during cardiopulmonary bypass by poc blood gas analyzer.Values were rechecked with the same result.Perfusionist started troubleshooting the equipment.The vaporizer was replaced and values returned to normal.

• Brand Name: HEART-LUNG MACHINE
• Type of Device: HEART-LUNG MACHINE
• Manufacturer (Section D): SORIN GROUP USA; arvada CO
• MDR Report Key: 6636313
• MDR Text Key: 77524536
• Report Number: MW5070353
• Device Sequence Number: 2
• Product Code: DTQ
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/24/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: S5
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/09/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR