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

Model Number 2426-0007

Device Problems Fluid/Blood Leak (1250); Stretched (1601); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Patient information requested but not provided.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 there was a large bubble in the tubing close to the valve and it sprayed the staff as they were trying to connect.There was no patient injury with this event.

Manufacturer Narrative

The customer¿s report that there was a large bubble in the tubing was confirmed by visual inspection.The customer also reported that the tubing sprayed (leaked) but limited functional testing did not observe any leaks.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.At the top of the silicone pump segment tubing near the upper fitment, a balloon was observed.Functional testing was performed and the set reprimed successfully via gravity with no signs of leaks or anomalies.Previous failure investigations have found that ballooning can occur when an iv push medication or flush is executed below the pump without first clamping the tubing above the injection port.This action was found to result in excessive pressure within the silicone segment thus causing the silicone segment to balloon.The root cause for the source of the excessive pressure is unknown.The customer¿s report that the tubing sprayed (leaked) was not confirmed.The root cause was not identified.

Event Description

It was reported that there was a large "bubble" in the tubing close to the valve and it sprayed the staff as they were trying to connect.It was further confirmed, that there was no patient harm as a result of this event.

• 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: 9549871
• MDR Text Key: 191449884
• Report Number: 9616066-2020-00023
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403227998
• UDI-Public: 10885403227998
• 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: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2022
• Device Model Number: 2426-0007
• Device Catalogue Number: 2426-0007
• Device Lot Number: 19105558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1