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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 07/22/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. 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 2ss 15m experienced missing label information. The following information was provided by the initial reporter: clinical staff confirmed that the wrong tubing set was grabbed on this occasion. Upon interviewing clinical staff at our sites, we realized that there have been several instances in which the tubing ref. 24302-0004 (which does not have a back check valve) was mistakenly used for a regular secondary infusion (instead of the set ref. 2420-0007). Though some of these events have not been formally reported to us, we believe they are of high importance at the moment due to their prevalence, likelihood of reoccurrence, and the risk they impose on our patients. We believe that there may have been a few contributing factors to this issue: the packaging for the tubing set ref. 24302-0004 is missing the description of parts. It is unclear where one could find the lot number and the expiry date in the packaging for these sets. We still hope that these pieces of information will, one day, be added to the tubing somehow rather than just to the packaging. In this way, it will be easier for customers and bd to identify a potential faulty lot of infusion sets.
 
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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 Key12346106
MDR Text Key267436770
Report Number9616066-2021-51843
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,Followup
Report Date 08/24/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/19/2021
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 Received08/24/2021
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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