MAUDE Adverse Event Report: CAREFUSION TEXIUM SECONDARY SET; IV TUBING

Catalog Number 72213NT

Device Problem Chemical Spillage (2894)

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

Event Date 05/27/2015

Event Type  malfunction  

Event Description

(b)(4).Patient was receiving chemotherapy.He received an hour paclitaxol infusion with no issues.At 13:57 carboplatin (1-hour) infusion was hung.At approximately 14:40 patient pulled his call light and reported that his chemotherapy was leaking.Infusion was stopped at this time.Upon inspection, the secondary tubing was leaking at the "bonded" texium end where it connected with the upper "y" site of the primary tubing (above infusion pump).Upon inspection, patient had received most of the drug via his iv.An estimated 10-15 ml of the drug had leaked onto the iv pole tray, iv pump, and small amount on floor.Patient informed me he had reached over and touched the spill when he noticed it.Instructed patient to wash hands with soap and water immediately.Notified pharmacy of spill.Pharmacist assisted rn (reporter) to clean up spill per protocol.Pharmacy changed secondary tubing set on chemotherapy.Re-initiated chemotherapy infusion and the leaking started again at end of secondary tubing.Cleaned up leakage per protocol agin.Pharmacy then changed both the primary tubing set and the secondary tubing set.Chemotherapy was started again with all new tubing and this time infusion was completed without issue.

• Brand Name: TEXIUM SECONDARY SET
• Type of Device: IV TUBING
• Manufacturer (Section D): CAREFUSION
• MDR Report Key: 4935687
• MDR Text Key: 6016291
• Report Number: MW5044614
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 07/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Catalogue Number: 72213NT
• Device Lot Number: 14046512
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR