MAUDE Adverse Event Report: BD /CAREFUSION 303 INC BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2426-0007

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 06/03/2020

Event Type  malfunction  

Event Description

The secondary bag of zosyn emptied into the flush bag and was y-d into the primary maintenance fluids going.Had to discontinue tubing and restart new bag of zosyn; questioning pump/cassette malfunction vs tubing.Fda safety report id# (b)(4).

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD /CAREFUSION 303 INC; franklin lakes NJ 07417 1880
• MDR Report Key: 10148009
• MDR Text Key: 195105998
• Report Number: MW5094955
• 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: 06/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/08/2023
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: (01)10885403227998
• Was Device Available for Evaluation?: No
• 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: 32 YR
• Patient Weight: 86