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

Model Number 2429-0500

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Information (3190)

Event Date 04/21/2019

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

It was reported that the tubing set had a hole in it and leaked.

Manufacturer Narrative

The customer¿s report of a tubing set with a hole and leak was confirmed and replicated during testing.During visual inspection, it was observed immediately that the pvc tubing had a slice cut approximately 5 ½ inches below the drip chamber.The slice cut was measured to be 0.13" inches long.Functional testing was performed by attaching the set to a bag filled with tap water and allowing fluid to flow through the set via gravity.A leak was immediately observed from the slice cut in the pvc tubing.The root cause of the slice cut was not identified.

Event Description

It was reported that the tubing set had a hole in it and leaked.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8649758
• MDR Text Key: 146367612
• Report Number: 9616066-2019-01474
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403228018
• UDI-Public: 10885403228018
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2429-0500
• Device Catalogue Number: 2429-0500
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1