MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET

Model Number 2420-0007

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2020

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 a kink was noticed in the as lvp 20d 2ss cv tubing below the drip chamber.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "while preparing infusion lines for treatment it is noted that there is kinking in the tubing right below the drip chamber.Unable to infuse on pump due to kink? fluid difficult to go through.Primed with saline solution.Noted prior to set being used in patient care.".

Event Description

It was reported that a kink was noticed in the as lvp 20d 2ss cv tubing below the drip chamber.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "while preparing infusion lines for treatment it is noted that there is kinking in the tubing right below the drip chamber.Unable to infuse on pump due to kink? fluid difficult to go through.Primed with saline solution.Noted prior to set being used in patient care.".

Manufacturer Narrative

H6: investigation summary a complaint of kinked tubing below the drip chamber was received from the customer.No product or photo was returned by the customer.The customer complaint of tubing kinked could not be verified due to the product not being returned for failure investigation.A device history record review for model 2420-0007 lot number 20075382 was performed.The search showed that a total of 34,563 units in 1 lot number was built on (b)(6) 2020.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 this failure was not identified as no product was returned.

• Brand Name: AS LVP 20D 2SS 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: 11092801
• MDR Text Key: 250584439
• Report Number: 9616066-2020-20689
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 37613203021020
• UDI-Public: 37613203021020
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/13/2021

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: Other
• Device Expiration Date: 07/03/2023
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 20075382
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/13/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1