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

Model Number 2420-0007

Device Problem Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

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 there was a bubble in the pump segment.There was no patient harm.Although requested, additional information was not provided.

Manufacturer Narrative

The customer¿s report that there was a bubble in the pump segment was confirmed during visual inspection.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed within the tubing throughout the set.At the top of the silicone pump segment tubing near the upper fitment, a balloon was observed.Functional testing of previous complaints with the failure mode of ¿balloon/bulge in silicone tubing segment¿ was performed by placing the infusion set in an alaris pump module and closing the door, programming/running the infusion, pausing the infusion, and then injecting an iv push fluid bolus through a distal y-site of the infusion set.Testing included injecting an iv push bolus after clamping the tubing (below the pump segment but above the iv push site per the dfu) and injecting the iv push bolus without clamping the tubing.Ballooning was not replicated in any clamped testing but has been replicated in unclamped testing when the tubing had been visually observed to be compromised (from previous ballooning).The root cause for the source of the excessive pressure is unknown.

Event Description

It was reported that there was a "bubble" in the pump segment.It was stated that there was no patient harm as a result of this event.Although requested, additional patient and event information was not provided.

• 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: 9608543
• MDR Text Key: 179426842
• Report Number: 9616066-2020-00199
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• 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,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/06/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19115490
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1