MAUDE Adverse Event Report: CAREFUSION 303, INC. BD ALARIS 8300 ETCO2 MODULE; ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE

Model Number 8300 ETCO2

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem Insufficient Information (4580)

Event Date 05/05/2021

Event Type  malfunction  

Event Description

Biomedical equipment technician noticed recurring defect in several bd alaris 8300 etco2 modules (25/29 units affected).The plastic posts holding the casing in place are deteriorated.Fluids are getting past the gasket and getting into the unit.Most of these units have otherwise no body damage, and no evidence of being dropped.Posts cannot be repaired, or replaced independently; therefore, cost of repair is approx $400 per unit.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS 8300 ETCO2 MODULE
• Type of Device: ANALYZER, GAS, CARBON-DIOXIDE, GASEOUS-PHASE
• Manufacturer (Section D): CAREFUSION 303, INC.
• MDR Report Key: 11797005
• MDR Text Key: 250061643
• Report Number: MW5101252
• Device Sequence Number: 1
• Product Code: CCK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8300 ETCO2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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