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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 PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2023
Event Type  malfunction  
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported while using bd alaris pump module smartsite infusion set the components separated.There was no report of patient impact.The following information was provided by the initial reporter: it seems they came apart at the part that goes in the channel, this happened to 2 different nurses.
 
Manufacturer Narrative
Investigation summary no photo or sample was received for the customer's complaint of separation.Without further information like a physical sample for investigation, the complaint cannot be verified and root cause of this failure remains unknown.A device history record review for model 2420-0500 lot number 22103538 was performed.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.
 
Event Description
It was reported while using bd alaris pump module smartsite infusion set the components separated.There was no report of patient impact.The following information was provided by the initial reporter: it seems they came apart at the part that goes in the channel, this happened to 2 different nurses.
 
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Brand Name
BD ALARIS PUMP MODULE SMARTSITE INFUSION SET
Type of Device
INTRAVASCULAR 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 Key16400635
MDR Text Key310179806
Report Number9616066-2023-00237
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203012448
UDI-Public(01)37613203012448
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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,Followup
Report Date 02/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/17/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number22103538
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/22/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/10/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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