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 11/14/2020

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 1st 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

The following fields were updated due to additional information: d10/d11: concomitant medical products: device available for eval yes.D10/d11: concomitant medical products: returned to manufacturer on: 2021-01-20.H6: investigation summary: pictures were sent in from the customer where the kinks are shown.One sample was returned for investigation.Through visual inspection, no kinks could be found in the tubing.However, separation was found at the drip chamber (p/n:630-00362) connection site with the sets tubing (p/n:660132).The inner diameter of the set was measured to be 0.127".The specified inner diameter for this tubing is 0.107" +/- 0.003.The set is within the required inner diameter range.When looking at the two components under the microscope, no traces of solvent could be seen on either the tubing or the drip chamber.The root cause for the separation is error during the assembly process.If the set is coiled and packaged prior to added solvent fully drying the connection site can kink and sometimes separate.

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 1st 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.".

• 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: 11088796
• MDR Text Key: 224117136
• Report Number: 9616066-2020-20665
• 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

• Date FDA Received: 12/29/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1