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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 LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE LOW SORBING INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10010453
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/27/2023
Event Type  malfunction  
Event Description
It was reported while using bd alaris pump module smartsite low sorbing infusion set there were flow issues.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: when we go to prime the lipid emulsions through the tubing, the lipid gets stuck in the filter.
 
Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
Possible lot number: d4: medical device lot #: 22125445 d4: medical device expiration date: 20dec2025 h4: device manufacture date: 20dec2022 the following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 13-feb-2023.H6: investigation summary: three samples (model #10010453) were returned for investigation.It was reported by the customer that when attempting to prime the lipids, they get stuck in the filter.The sets were examined for defects and abnormalities.No defects or abnormalities were observed.The sets arrived with lipids throughout the tubing, in the filter and past the filter.No excess solvent was seen at the ports of the filter.The sets were flushed with water, and then successfully primed with 85% glycerin / 15% water solution.No occlusions were observed.The failure was unable to be replicated.A root cause was unable to be determined because the failure was unable to be replicated.For additional information regarding the use of ivfe with in-line filter administration sets see the attached ¿filtering out the facts: recommendations to optimize performance of in-line filters for parenteral nutrition and intravenous fat emulsion infusions (ivfe)." bd is looking at opportunities to improve the filter function to alleviate this failure in the future.A lot number is unknown, however, a possible lot was identified to be: 22125445 a device history record review for model 10010453 and possible lot number 22125445 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.
 
Event Description
It was reported while using bd alaris pump module smartsite low sorbing infusion set there were flow issues.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: when we go to prime the lipid emulsions through the tubing, the lipid gets stuck in the filter.
 
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Brand Name
BD ALARIS PUMP MODULE SMARTSITE LOW SORBING 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
8448235433
MDR Report Key16427778
MDR Text Key310332136
Report Number9616066-2023-00247
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021143
UDI-Public(01)37613203021143
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 03/22/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number10010453
Device Catalogue Number10010453
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/22/2023
Was Device Evaluated by Manufacturer? Yes
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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