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 11/28/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the ivt line disconnected from the as lvp 20d 2ss cv while attaching the filter.The following information was provided by the initial reporter: "issue with our ivt line, which became disconnected from main part during process of attaching to filter to put on tpn.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval? yes.D10: returned to manufacturer on: 2020-12-23.Investigation summary: one (b)(4) sample was received for investigation without packaging; residual fluid was present.Additionally a pall filter extension set was received connected to the sample to assist the investigation.A visual inspection of the (b)(4) sample confirmed the customer's experience as a separation was identified at the male luer tubing joint.A closer inspection did not identify signs of residual solvent.The details of this feedback were forwarded to the manufacturing site for investigation.A definitive root cause for the separation could not be determined in this instance; however it is likely that the operator inadvertently missed the assembly step where solvent is applied to the male luer prior to the components being connected.This is a manual assembly process and is likely to have occurred due to human error.In this instance a lot number was not available and therefore it is not possible to perform a review of the production documentation for this particular product.The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product.A review of the customer feedback database indicates that this is a rare occurrence with a very small number of similar reports against the (b)(4) set in the past 12 months.

Event Description

It was reported that the ivt line disconnected from the as lvp 20d 2ss cv while attaching the filter.The following information was provided by the initial reporter: "issue with our ivt line, which became disconnected from main part during process of attaching to filter to put on tpn.".

• 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: 11091407
• MDR Text Key: 250333567
• Report Number: 9616066-2020-20675
• 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: 01/14/2021

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: Health Professional
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Manufacturer Received: 12/01/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/14/2021
• Supplement Dates FDA Received: 01/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1