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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 Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD Y EXT W/VLV PORTS & 2 SLD CLP INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 20019E7D
Device Problems Backflow (1064); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/06/2021
Event Type  malfunction  
Event Description
It was reported that 2 bd y ext w/vlv ports & 2 sld clp leaked and had blood backflow during infusion. The following information was provided by the initial reporter: "after administering the medication there is a backflow of blood and fluid coming out from the smartsite extension adapter. ".
 
Manufacturer Narrative
Investigation summary: a 20019e7d product was not available for investigation; however the customer confirmed that the complaint sample was from lot 21075725. From the information provided by the customer it appears that backflow of blood occurred from the patient, and leakage was observed from the smartsite. As part of the feedback the customer provided a video of the affected smartsites; analysis of the video confirmed the customer's experience as leakage was observed from the piston of the smartsite. Further information provided by the customer also indicates that the smartsite was oval in shape. The details of this feedback were forwarded to the manufacturing site for investigation. A review of the production records for lot 21075725 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. Please note, the root cause of the oval shape is exposure of the smartsite to an external heat source that brings the component temperature above 60°c. The piston head of the smartsite is oval shaped therefore when the round fla component is placed over it, the piston opening is squeezed shut in order to create a seal. Under excessive heat conditions, the fla material can soften, and as the piston pushes back on the inside, it can reshape the fla to conform to the original oval shape of the piston head. Previous investigations have not found a potential root cause for this level of excess heat as a result of any stage of the manufacturing or sterilization processes at the manufacturing site. A review of the customer feedback database indicates that there is no increased trend for oval smartsite valves. It is possible that there is a local environmental factor that has caused the product to reach the elevated temperature required to cause this issue (e. G. During storage or transit).
 
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Brand NameBD Y EXT W/VLV PORTS & 2 SLD CLP
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 Key12929769
MDR Text Key284985875
Report Number9616066-2021-52537
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeIN
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
Report Date 11/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number20019E7D
Device Lot Number21075725
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/09/2021
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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