MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY / CAREFUSION 303, INC. BD - ALARIS SECONDARY IV TUBING SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 72213N

Device Problem Failure to Infuse (2340)

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

Event Date 03/04/2019

Event Type  malfunction  

Event Description

An antibiotic was hung properly on a secondary line and was unclamped.Staff rounding on the patient after the infusion began noted the antibiotic was not infusing and the pump was showing the rate that the primary/carrier fluid was infusing so only the primary/carrier fluid was infusing.Staff reprogrammed the pump for the antibiotic's correct dose, volume, and rate and restarted it.The antibiotic began infusing and fully infused.Review of the pump data log showed the antibiotic was programmed as a secondary using integration at 2255 and ran at a rate of 200 mls/hr for 30 minutes and then transitioned back to the primary rate of 75mls/hr.

• Brand Name: BD - ALARIS SECONDARY IV TUBING SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY / CAREFUSION 303, INC.; franklin lake NJ 07417
• MDR Report Key: 8414079
• MDR Text Key: 138700551
• Report Number: MW5084833
• Device Sequence Number: 0
• 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: Nurse
• Type of Report: Initial
• Report Date: 03/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/17/2021
• Device Model Number: 72213N
• Device Lot Number: (10)18106336
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2019
• 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: 59 YR