MAUDE Adverse Event Report:; TUBING, FLUID DELIVERY

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

Event Date 10/13/2014

Event Type  malfunction  

Event Description

Arsenic trioxide was hung onto pole and tubing was placed in iv pump, not connected to patient when chemo started leaking from tubing inside pump onto the floor.Chemo and tubing were removed and placed inside chemo bag.Small hole was discovered in "stretchy part" of tubing located inside pump chamber.Charge nurse notified, chemo pharmacist notified.Spill kit and appropriate ppe was used to clean spill, iv pump and pole cleaned and removed from patient room.Chemo did not come into contact with patient or clothing.

• Brand Name: UNK
• Type of Device: TUBING, FLUID DELIVERY
• MDR Report Key: 4284247
• MDR Text Key: 5225646
• Report Number: 4284247
• Device Sequence Number: 1
• Product Code: FPK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 11/03/2014

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: Nurse
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/03/2014
• Patient Sequence Number: 1