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

Catalog Number MS3500-15

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2024

Event Type  malfunction  

Event Description

It was reported that bd as lvp 20d 2ss cv content did not flow.The following information was provided by the initial reporter: 2.1.24- keppra secondary piggyback administration initiated for icu patient from existing tubing.Set up for primary as kvo, and secondary as keppra administration.Programmed pump and started infusion without issue.Infusion was to be completed in 15 minutes.Other tasks for patient completed and in 15 minutes returned to pump and ns had infused not the keppra in the secondary bag.Assessed pump, tubing, patient.Restarted chamber and same issue occurred with ns infusing, not medication.All tubing replaced and re-hung and infused to patient appropriately.Equipment/supplies involved- bd pump infusion set back check valve ref (b)(4).Bd secondary set (vented/nonvented) m53500-15.Alaris brain and channels not evaluated as this was felt to be a secondary or primary set tubing issue.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E1.Address information was not provided, therefore, xx was used as a place holder.

• Brand Name: AS LVP 20D 2SS CV
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18832311
• MDR Text Key: 337750114
• Report Number: 9616066-2024-00355
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: (01)07613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221327
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MS3500-15
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1