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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¿ LOW SORBING EXTENSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20350E
Device Problems Complete Blockage (1094); Restricted Flow rate (1248); Device Contamination with Chemical or Other Material (2944)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 08/09/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported that the bd alaris¿ smartsite¿ low sorbing extension set tpn line was blocked, building pressure in the chamber and causing tpn fluid backing up from the filter to turn "cloudy". The following information was provided by the initial reporter: "the tpn line was blocked and pressure building up in the chamber, all vents opened and clamps unclamped. Second rn to verify and troubleshoot, had same issue. Tpn fluid backing up from filter into chamber appearing cloudy. Unable to pull air bubbles out with syringe. Disconnected line to try to run fluid through it, and completely blocked with all clamps opened. Defective iv tubing. ".
 
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Brand NameBD ALARIS¿ SMARTSITE¿ LOW SORBING EXTENSION 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
MDR Report Key12471037
MDR Text Key271540670
Report Number9616066-2021-52046
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K960280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 09/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20350E
Device Catalogue Number20350E
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
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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