MAUDE Adverse Event Report: CAREFUSION, ALARIS SMARTSITE INFUSION SET; SMARTSITE INFUSION SET, 20 DROP

Catalog Number 2426-0500

Device Problems Leak/Splash (1354); Material Separation (1562); Split (2537)

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

Event Date 06/07/2015

Event Type  malfunction  

Event Description

Alaris tubing "smartsite infusion set ref #2426-0500" has a specially designed pump segment.On the same pump, same pt, within the same time frame - one set developed a bulge in tubing measure length 1-3/8", diameter 7/8".Pump continued to deliver but unable to determine accuracy.Changed primary tubing, same set #, same pump, same pt, same drug - one set split/ruptured at the top of the pumping segment, separating from the top of the tubing and leaking fluid everywhere.

• Brand Name: SMARTSITE INFUSION SET
• Type of Device: SMARTSITE INFUSION SET, 20 DROP
• Manufacturer (Section D): CAREFUSION, ALARIS; san diego CA
• MDR Report Key: 4847380
• MDR Text Key: 5872545
• Report Number: MW5043064
• Device Sequence Number: 1
• Product Code: FPA
• 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: 06/08/2015

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 Catalogue Number: 2426-0500
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/08/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other