MAUDE Adverse Event Report: BECTON DICKINSON & CO. ALARIS TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number 10014917

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 08/26/2021

Event Type  malfunction  

Event Description

Carefusion syringe administration set smallbore tubing with pressure sensing disc ref (b)(4) the patient came up from the er with the insulin running on a syringe pump with this syringe pump tubing on the insulin.It was running at 1.33 ml/h and was running without problems.The pressure sensor on the line was showing about 1/6 of the line of pressure.During the shift the syringe pump kept beeping occlusion without the sensor bar filling up.This was resolved by the patient straightening out his arm and reset.The iv was in his ac.This was happening about every hour or so, after a while i changed out the syringe pump to see if that would resolve the issue, but it did not.Around 0400 i brought in new tubing, re-primed the new tubing milking the disk and restarted the insulin drip on the syringe pump.This time the pressure bar was not there on the channel and the pump ran without problems.Fda safety report id# (b)(4).

• Brand Name: ALARIS TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BECTON DICKINSON & CO.; franklin lakes NJ 07417
• MDR Report Key: 12512901
• MDR Text Key: 272901048
• Report Number: MW5104122
• Device Sequence Number: 1
• Product Code: FPA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Type of Report: Initial
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 10014917
• Was Device Available for Evaluation?: 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: 10 YR