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

Model Number 2477-0007

Device Problem Infusion or Flow Problem (2964)

Patient Problem Insufficient Information (4580)

Event Date 02/05/2023

Event Type  malfunction  

Event Description

Rn was administering 1 unit prbc.When checking on blood and volumes already infused- the blood volume infused on pump was more than volume in bag and there was still blood in bag to be infused.Prbc bag volume was 300.Pump saying around 500 was infused.Rn noticed blood was lighter than normal and saline bag volume was down.Saline clamp was closed but appears to still have been infusing diluting the blood that was already infusing.

• 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: 16452126
• MDR Text Key: 310345094
• Report Number: 16452126
• 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: 02/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2477-0007
• Device Catalogue Number: 2477-0007
• 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: 02/09/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 20075 DA
• Patient Sex: Male
• Patient Weight: 20 KG
• Patient Race: White