MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2017

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

The customer reported that while a pump was infusing, the nurse saw a bulge burst in the tubing creating a hole which leaked fluid.There was no patient harm.

Event Description

The customer reported that while a pump was infusing, the nurse saw a bulge in the pump segment.The bulge ruptured creating a hole which leaked fluid.There was no patient harm.

Manufacturer Narrative

The customer¿s report of a bulge in the pump segment which ruptured and leaked was not confirmed however a tear in the tubing at a different location was confirmed.Initial visual inspection revealed no bulge or other anomalies.Functional testing was performed and the set leaked from the tubing approximately 2 inches below the tubing adaptor where the roller clamp was engaged.Closer inspection under magnification showed a jagged tear in the tubing approximately 0.312 in long.The cause of the tubing leak is a tear in the tubing.The root cause of the tear could not be identified.

• Brand Name: ALARIS® PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7300909
• MDR Text Key: 101168688
• Report Number: 9616066-2018-00219
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 02/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2020
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 17093009
• Other Device ID Number: 7613203021012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2018
• Date Manufacturer Received: 05/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015, TD (B)(6) 2017