MAUDE Adverse Event Report: BD ALARIS PUMP INFUSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2420-0007

Device Problems Insufficient Flow or Under Infusion (2182); Material Twisted/Bent (2981)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/27/2022

Event Type  malfunction  

Event Description

Pressors requirements kept increasing with low bp despite levophed infusing via alaris pump.Changed iv sites, no change in bp, changed iv tubing.Bp normalizing.Upon inspection of iv tubing, it is noticed there is a kink in the tubing within the pump channel.The medication was not priming through the tubing even though the clamp was open.Tubing saved and given to unit director.Fda safety report id# (b)(4).

• Brand Name: ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 15138110
• MDR Text Key: 297048883
• Report Number: MW5111187
• 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: 07/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2420-0007
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LEVOPHED
• Patient Age: 84 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White