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 Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/26/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that as lvp 20d 2ss cv had a check valve malfunction.The following information was provided by the initial reporter: material no: 2420-0007, batch no: 20075382, it was reported that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.Verbatim: date of incident (yyyy-mm-dd): (b)(6) 2020.Type of incident/problem: malfunction - during or after use.Level of harm: no effect - did not reach patient - detected before use or does not touch person during use.Ahs optional report to (b)(6)): yes.Incident details: infusion nurse was administering chemotherapy to patient.Systemic agent was attached to the y-site port below the drip chamber and back flow priming of secondary tubing was complete.Once line was placed into the alaris pump the primary bag of ns continued to fill the systemic therapy bag with ns.Nurse noticed immediately and clamped secondary to stop back flow from occurring.With back flow continuing the systemic bag would fill and dilute drug further therefore patient would receive more fluids that are not required.Secondary tubing removed and placed on new line for administration.Who was affected? no person affected.Frequency of problem: recurring.

Manufacturer Narrative

Investigation summary: one photo was received from the customer which verifies the customer complaint that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.No product was returned.A device history record review for model 2426-0007, lot number 19125907 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.

Event Description

It was reported that as lvp 20d 2ss cv had a check valve malfunction.The following information was provided by the initial reporter: material no: 2420-0007, batch no: 20075382.It was reported that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns.Verbatim: date of incident (yyyy-mm-dd): (b)(6) 2020.Type of incident/problem: malfunction - during or after use? level of harm: no effect - did not reach patient - detected before use or does not touch person during use.Ahs optional report to (b)(6): yes.Incident details: infusion nurse was administering chemotherapy to patient.Systemic agent was attached to the y-site port below the drip chamber and back flow priming of secondary tubing was complete.Once line was placed into the alaris pump the primary bag of ns continued to fill the systemic therapy bag with ns.Nurse noticed immediately and clamped secondary to stop back flow from occurring.With back flow continuing the systemic bag would fill and dilute drug further therefore patient would receive more fluids that are not required.Secondary tubing removed and placed on new line for administration.Who was affected? no person affected.Frequency of problem: recurring.

• 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: 11101596
• MDR Text Key: 246119989
• Report Number: 9616066-2020-20698
• 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: 01/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Date Manufacturer Received: 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1