MAUDE Adverse Event Report: CAREFUSION 303, INC. ALARIS, SMARTSITE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0500

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Exposure to Body Fluids (1745); Chemical Exposure (2570)

Event Date 09/23/2020

Event Type  malfunction  

Event Description

Middle aged female with the history of hypertension disorder, deep vein thrombosis, anemia and systemic lupus.While receiving 1 unit of packed red blood cells in the outpatient infusion area, the pump paused.Blood line of dual line tubing clamped, saline line opened.Started pump back up at a rate of 200 and immediately the tubing became disconnected directly below the drip chamber causing saline/blood mixture to be expelled into the air contaminating both the patient and rn.This is the second time this tubing has come apart in the same place.Please refer to (b)(4).Manufacturer response for bd alaris pump infusion blood set, (brand not provided) (per site reporter): purchasing department notified the second time this has happened in 2 weeks.

• Brand Name: ALARIS, SMARTSITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC.; 10020 pacific mesa blvd; san diego CA 92121
• MDR Report Key: 10634679
• MDR Text Key: 210001160
• Report Number: 10634679
• Device Sequence Number: 1
• Product Code: FPA
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2020
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 15330 DA
• Patient Weight: 81