MAUDE Adverse Event Report: CAREFUSION CAREFUSION; PRIMARY IV PUMP TUBING FOR CHEMO

Catalog Number 10015862

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Date 11/25/2015

Event Type  malfunction  

Event Description

Vincristine was being administered in the outpatient pediatric infusion center at a rate of 900ml/hr to infuse over 5 minutes via primary chemo tubing via an alaris pcu and large volume module.Treatment of acute leukemia (all) in remission.The patient stated that he felt something dripping.When investigating the tubing it was found to have a leak at the drip chamber above the pump.Due to the nature of the vesicant being administered, chemo precautions and spill management began including washing the patient's skin with soap and water for 10-15 minutes and removal and disposal of his sock as there were traces of the medication on it as well.No further medication or interventions made.Recurring event over time.One time use for this event.

• Brand Name: CAREFUSION
• Type of Device: PRIMARY IV PUMP TUBING FOR CHEMO
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 5273167
• MDR Text Key: 32979178
• Report Number: MW5058355
• Device Sequence Number: 1
• Product Code: CAR
• 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: 12/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 10015862
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 42