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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE .2MF PED INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 10011865
Device Problem Leak/Splash (1354)
Patient Problems Hypoglycemia (1912); Low Blood Pressure/ Hypotension (1914)
Event Date 05/31/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that ext set smallbore. 2mf ped leaked. The following information was provided by the initial reporter: it was reported that the filter is where they have had issues affecting the patient indicating there might be a leak. Verbatim: the filter is where we seem to have had issues that actually affected the patient. Our umbilical arterial lines start backing up indicating there might be a leak but that seems to correct after changing out the filter. The patient issues have involved blood glucose being low and blood pressure dropping after changing tubing indicating a possible leak in the filter so that the dopamine for blood pressure or glucose in iv fluids isn't reaching the patient. These have appeared to have corrected after changing out the filter.
 
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Brand NameEXT SET SMALLBORE .2MF PED
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 Key12081694
MDR Text Key263536684
Report Number9616066-2021-51410
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
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 06/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number10011865
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/15/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/01/2021
Was Device Evaluated by Manufacturer? No
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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