MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS, CORP. CDI BLOOD BLOOD PARAMETER MONITORING SYSTEM 500; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number N/A

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Information (3190)

Event Date 01/21/2014

Event Type  malfunction  

Event Description

Cdi 500 in line blood gas monitor failed to read hct and venous sat during case.Venous gas was run during trouble shooting.A new cdi 500 machine was brought into or and placed on cells, worked fine.Other unit will be sent in for repair.

• Brand Name: CDI BLOOD BLOOD PARAMETER MONITORING SYSTEM 500
• Type of Device: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS, CORP.; 6200 jackson road.; ann arbor MI 48103
• MDR Report Key: 3779268
• MDR Text Key: 4440950
• Report Number: 3779268
• Device Sequence Number: 1
• Product Code: DRY
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Model Number: N/A
• Device Catalogue Number: 500AHCT
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/11/2014
• Event Location: Hospital
• Date Report to Manufacturer: 04/30/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/11/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NOT APPLICABLE.
• Patient Age: 8 YR
• Patient Weight: 40