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

Catalog Number 2430-0500

Device Problems Leak/Splash (1354); Gas/Air Leak (2946)

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

Event Date 02/11/2019

Event Type  malfunction  

Event Description

Rn went to hang bag of tpn on patient.Bag scanned, spiked, rn primed tubing, clamped tubing and put tubing into alaris pump.Rn was prepping to attach tubing to patient when rn noted that tpn was dripping out of the end of the tubing.Rn double checked that roller clamp was closed and it was.Tpn continued to leak out of the tubing but no drips were dripping in the drip chamber.Rn noted at the end of the tubing right behind the male luer a large air bubble was forming in the tube as the tpn was dripping out of the tube.Thought that the tube either has a hole or a faulty connection.This tubing was going to be hooked up to a port.Rn immediately removed tubing from patient¿s bedside and got a new iv filter set.

• Brand Name: BD ALARIS PUMP INFUSION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BD
• MDR Report Key: 8336893
• MDR Text Key: 136881163
• Report Number: MW5084007
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Catalogue Number: 2430-0500
• Device Lot Number: 1018105874
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/12/2019
• 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: 74 YR
• Patient Weight: 71