MAUDE Adverse Event Report: CAREFUSIONS CAREFUSION SMARTSITE LOW SORBING INFUSION

Model Number 10010454

Device Problems Disconnection (1171); Chemical Spillage (2894)

Patient Problem No Code Available (3191)

Event Date 11/06/2017

Event Type  Injury  

Event Description

When preparing chemotherapy infusions, we use a product by carefusion (smartsite low sorbing infusion set).On two separate instances, we prepared a chemotherapy infusion using this tubing, and the roller clamp essentially fell apart (disconnected) on its own.This could result in the inadvertent spilling of chemotherapy.

• Brand Name: CAREFUSION SMARTSITE LOW SORBING INFUSION
• Type of Device: SMARTSITE LOW SORBING INFUSION
• Manufacturer (Section D): CAREFUSIONS; ch
• MDR Report Key: 7013683
• MDR Text Key: 91872721
• Report Number: MW5073211
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203015806
• UDI-Public: (01)07613203015806
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 11/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2020
• Device Model Number: 10010454
• Device Lot Number: 0761320301580617087089
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Required Intervention