MAUDE Adverse Event Report: CAREFUSION CORPORATION BLENDER; MIXER, BREATHING GASES, ANESTHESIA INHALATION

Model Number 10047A

Device Problems Loose or Intermittent Connection (1371); Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Patient is on ecmo-post oxygenator pao2 reading 70, oxygen tubing/filter changed without improvement.Changed post oxygenator pao2 greater than 500.Blender dial knob found to be loose.Analyzer check reading = 21%.

• Brand Name: BLENDER
• Type of Device: MIXER, BREATHING GASES, ANESTHESIA INHALATION
• Manufacturer (Section D): CAREFUSION CORPORATION; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 8499538
• MDR Text Key: 141468239
• Report Number: 8499538
• Device Sequence Number: 1
• Product Code: BZR
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10047A
• Device Catalogue Number: 10047A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/27/2019
• Device Age: 18 YR
• Event Location: Hospital
• Date Report to Manufacturer: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 DA
• Patient Weight: 2