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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE GRAVITY BLOOD SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS SMARTSITE GRAVITY BLOOD SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 42081E-0006
Device Problem Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/25/2022
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 while using bd alaris smartsite gravity blood set the tubing was clogged and kinked. There was no report of patient impact. The following information was provided by the initial reporter: during connecting first blood transfusion bag the chamber is blocked from blood clot formation , also when releasing clamp the tube was compressed hardly as per the user it was clapmed for a while , and then when clamp released it did not open properly when the fluid start running.
 
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Brand NameBD ALARIS SMARTSITE GRAVITY BLOOD SET
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13862370
MDR Text Key287704412
Report Number9616066-2022-00296
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeSA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number42081E-0006
Device Lot Number20086650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/11/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/31/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/28/2020
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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