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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 15M INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS 15M INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 24302-0004
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2021
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a photo was received from the customer for quality investigation. The customer provided feedback that the product that stated, "they mistakenly grabbed 24302-0004 for tubing 2420-0007. " evaluation of the photo provided shows that each product material number is clearly shown on the packaging of the different infusion sets, however, the components of the assembly for model 24302-0004 infusion set are not individually identified. A device history record review could not be performed on model 24302-0004 because a lot number was not provided by the customer. Marketing has been made aware of the issue and is working on ways to potentially enhancing the label to better identify the components of the assembly. 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 24302-0004 experienced missing label information. The following information was provided by the initial reporter: there has a new patient-related incident for an alaris tubing set 24302-0004 mistaken for the tubing 2420-0007. On this occasion, the set 24302-0004 was previously hung by another nurse for albumin infusion. In the following shift, this tubing was mistaken for a 2420-0007 by a different nurse who used it for a secondary infusion and immediately noticed the excessive flow rate. No patient harm was reported.
 
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Brand NameAS LVP 20D 2SS 15M
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 Key12378274
MDR Text Key268496148
Report Number9616066-2021-51911
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number24302-0004
Device Lot NumberUNKNOWN
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 Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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