MAUDE Adverse Event Report: BD BD ALARIS PUMP INFUSION BLOOD SET, 180 MICRON FILTER, SMARTSITE Y-SITE; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number (10)1904666

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 06/07/2019

Event Type  malfunction  

Event Description

Patients was receiving a unit of blood.It was being infused via alaris pump.Anesthesia wanted the blood out of the alaris pump.When rn opened the module there was blood on the tubing and inside the module.We disconnected the tubing and module.Finished the blood transfusion via blood tubing.Module in use was #11409, brain #11271; other modules: #07699, # 11397.Fda safety report id # (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION BLOOD SET, 180 MICRON FILTER, SMARTSITE Y-SITE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 8696083
• MDR Text Key: 148064098
• Report Number: MW5087320
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2022
• Device Lot Number: (10)1904666
• 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
• Patient Age: 35 YR