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U.S. Department of Health and Human Services

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

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0007
Device Problems Fluid Leak (1250); Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of birth: unknown. The patient¿s age was used. Investigation summary: one sample was received for quality investigation. The customer complaint of component damage was verified by visual inspection. Evaluation of the submitted sample revealed that the valve was missing the piston portion of the assembly. A device history record review for model 2426-0007 lot number 20065872 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 08jun2020. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. The root cause for the issue seen in this complaint is an issue during the manufacturing process of the y-site smartsite where piston was not installed during its construction. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the as lvp 20d 2ss cv leaked lumizyme medication when spiking the bag, and it was discovered that blue valve was missing from the y-site. The following information was provided by the initial reporter: "rn spiked pt's infusion bag of lumizyme, but quickly noticed tubing leaking. Rn stopped priming tubing and flipped bag upside down to stop the medication from leaking out. After inspecting tubing, rn noticed at the y-site closest to the drip chamber, the blue valve missing. New tubing applied to pt's medication bag".
 
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Brand NameAS LVP 20D 2SS CV
Type of DeviceINTRAVASCULAR ADMINISTRATION SET
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12138950
MDR Text Key260757163
Report Number9616066-2021-51482
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 06/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number20065872
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/17/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/08/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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