MAUDE Adverse Event Report: BECTON DICKINSON AND COMPANY BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION INTRAVASCULAR

Catalog Number 2426-0007

Device Problems Material Puncture/Hole (1504); Device Displays Incorrect Message (2591)

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

Event Date 06/08/2018

Event Type  malfunction  

Event Description

Fentanyl drip infusing when nursing staff responded to "air in line" alarm on the alaris pump.Nursing staff inspected the pump and tubing, found an area of concern on the drop chamber that appeared to be a puncture site.The tubing was exchanged.The facility has completed our review of the report.The remaining fentanyl in the tubing was removed and sent for analysis and the alaris pump was removed from service for evaluation.At this time there is not concern for altercation or diversion of the fentanyl that was being administered.The alaris pump has also been evaluated and functioned as intended.Facility inquiring add'l evaluation/info on the area of concern on the drip chamber of the tubing.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON AND COMPANY; franklin lakes NJ 07417
• MDR Report Key: 7670799
• MDR Text Key: 113516066
• Report Number: MW5078285
• 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: Nurse
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2426-0007
• 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: 46 YR