MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2426-0500

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the as lvp 20d dehp 3ss cv tubing had broken from the connector.The following information was provided by the initial reporter: "reporting another issue with product #: 2426-0500, alaris pump infusion set.On (b)(6) 2020 a nurse in our infusion unit was going to prime the iv for a patient.She opened the bd tubing and noticed right away it was broken at the y site below the pump segment.There was no patient harm or delay in care.".

Manufacturer Narrative

H6: investigation summary a sample was received in and the separation was immediately apparent verifying the customer's complaint.Visual inspection under microscope was performed and the root cause determined to be a shallow insertion in the junction where tubing meets y-site.A device history record review for model 2426-0500 lot number 20063383 was performed.The search showed that a total of 33,303 units in 1 lot number was built on 15jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h.10.

Event Description

It was reported that the as lvp 20d dehp 3ss cv tubing had broken from the connector.The following information was provided by the initial reporter: "reporting another issue with product #: 2426-0500, alaris pump infusion set.On (b)(6) 220 a nurse in our infusion unit was going to prime the iv for a patient.She opened the bd tubing and noticed right away it was broken at the y site below the pump segment.There was no patient harm or delay in care.".

• Brand Name: AS LVP 20D DEHP 3SS CV
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 11098598
• MDR Text Key: 225525607
• Report Number: 9616066-2020-20696
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021006
• UDI-Public: 37613203021006
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2023
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 20063383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Date Manufacturer Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1