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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 DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problems Complete Blockage (1094); Deformation Due to Compressive Stress (2889)
Patient Problem Insufficient Information (4580)
Event Date 06/24/2021
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.
 
Event Description
It was reported that the as lvp 20d dehp 2ss cv tubing kinked when the patient bent their arm while sleeping, causing the occlusion alarm to sound. This occurred several times through the night, leading to flow issues with the lower flow rate. The following information was provided by the initial reporter: "i am a medical resident working on a stroke rehabilitation floor and we have experienced a problem when operating the alaris pumps. We tend to give low flow rates to our patients over long periods of time. Last week we were infusing normal saline at a rate of 75ml/hr over 24 hours and the occlusion alarm on the alaris pump kept going off. This was because the patient kept bending their arm while they were sleeping and kinking set and/or the iv cannula. This required myself or the nurses to pause the infusion, straighten the patients arm and unkink the tubing. However, after the first couple of times, the tubing remained kinked and required massaging along the length of the set to stop the occlusion alarm from sounding. There were so many pauses due to this occlusion alarm that the patient was not receiving the proper amount of fluid. This is not the first time that something like this has happened, in fact it is a common occurrence on our floor due to the low flow rates and long periods of time that the iv is in for. ".
 
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Brand NameAS LVP 20D DEHP 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 Key12356744
MDR Text Key267895751
Report Number9616066-2021-51875
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number21043016
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/23/2021
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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