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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
Catalog Number 2426-0500
Device Problems Partial Blockage (1065); Restricted Flow rate (1248)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/09/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that 2 bd alaris¿ pump module smartsite¿ infusion set had damaged device usable and flow issues.The following information was provided by the initial reporter : the customer reported the tubing set is unable to prime and the pump alarms air in the line, stating there may be a hole in the tubing set.This has occurred on multiple occasions.
 
Event Description
It was reported that 2 bd alaris¿ pump module smartsite¿ infusion set had damaged device usable and flow issues.The following information was provided by the initial reporter: the customer reported the tubing set is unable to prime and the pump alarms air in the line, stating there may be a hole in the tubing set.This has occurred on multiple occasions.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 that 2 bd alaris¿ pump module smartsite¿ infusion set had damaged device usable and flow issues.The following information was provided by the initial reporter : the customer reported the tubing set is unable to prime and the pump alarms air in the line, stating there may be a hole in the tubing set.This has occurred on multiple occasions.
 
Manufacturer Narrative
Investigation summary no product or photo was returned by the customer.The customer complaint of component damage- no leak/ flow issues fluid blockage- complete occlusion could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0500 lot number 21093283 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on (b)(6) 2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.
 
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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 Key13192637
MDR Text Key285357253
Report Number9616066-2021-52691
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203020992
UDI-Public07613203020992
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 01/18/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2426-0500
Device Lot Number21093283
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/14/2021
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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