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

Model Number 2420-0007

Device Problems Material Separation (1562); Separation Failure (2547)

Patient Problem No Patient Involvement (2645)

Event Date 03/24/2020

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 when the tubing set was removed from the stockroom and the package opened, the tubing set was found to be separated from the blue safety clamp.There was no patient involvement.

Manufacturer Narrative

The customer¿s report that the primary tubing set separated and spilled (leaked) medication was confirmed.Visual inspection observed a separation at the engagement between the lower fitment and distal tubing.Closer inspection of the separated tubing under a lab microscope observed insufficient solvent at the end of the tubing during manufacturing.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.A device history record for model 2420-0007 with lot number 20013380 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 29jan2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the separation was identified as a manufacturing issue for insufficient solvent being applied at the engagements of the tubing due to equipment and/or operator error.

Event Description

It was reported that when the tubing set was removed from the stockroom and the package opened, the tubing set was found to be separated from the blue safety clamp.There was no patient involvement.

• 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: 9992855
• MDR Text Key: 195932868
• Report Number: 9616066-2020-01320
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/27/2020

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: 01/29/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20013380
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1