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

Model Number 2420-0500

Device Problems Fluid/Blood Leak (1250); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/07/2019

Event Type  malfunction  

Manufacturer Narrative

The devices have been received and the evaluation is pending.A follow up report will be submitted with investigation results once the evaluation has been completed.

Event Description

It was reported that the tubing came apart at the port below the drip chamber and leaked unknown fluid.No patient harm or caregiver was reported.

Manufacturer Narrative

The customer¿s report that the tubing came apart at the port below the drip chamber and leaked was confirmed based on visual inspection.The separation was at the engagement between the tubing and smartsite valve (inlet of upper valve) components.Further inspection of the separated tubing end identified the issue to be due to insufficient solvent being applied at the tubing engagement along with the tubing not being fully inserted.Dimensional measurement confirmed the tubing to be within specification.The set was visually inspected for kinks, holes/tears in the tubing or damages to the components.No other damages or issues were observed.No testing was deemed necessary due to the obvious separation.The root cause of the separation is due to a combination of factors related to insufficient solvent and improper assembly due to equipment and/or operator error.

Event Description

It was reported that the tubing came apart at the port just below the drip chamber and leaked an unknown fluid.It was confirmed during follow up, that there was no patient or caregiver harm, as a result of this event.

• 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: 9162999
• MDR Text Key: 161861779
• Report Number: 9616066-2019-02775
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203012430
• UDI-Public: 7613203012430
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 09/09/2019

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: Health Professional
• Device Expiration Date: 06/16/2022
• Device Model Number: 2420-0500
• Device Catalogue Number: 2420-0500
• Device Lot Number: 19063131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/07/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1