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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 TEXIUM SECONDARY SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS TEXIUM SECONDARY SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 40000-07T
Device Problems Material Separation (1562); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2021
Event Type  malfunction  
Event Description
It was reported that 2 bd alaris texium secondary sets experienced component separation. The following information was provided by the initial reporter: tubing came apart below drip chamber.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.
 
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Brand NameBD ALARIS TEXIUM SECONDARY 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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12916287
MDR Text Key284987915
Report Number9616066-2021-52524
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K790582
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 01/26/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number40000-07T
Device Catalogue Number40000-07T
Device Lot Number20095693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/16/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/26/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/02/2020
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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