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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 2426-0007
Device Problem Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/28/2022
Event Type  malfunction  
Event Description
It was reported that 2 bd alaris¿ pump module smartsite¿ infusion sets were found with kinked tubing, one during use and one still in the packaging.The following information was provided by the initial reporter: "1.Below the safety clamp - where the pinch clamp is located below the safety clamp, an indent in the tubing is formed which triggers an alarm when placed in the pump.2.Below the drip chamber - as the tubing is packaged, the drip chamber is found bent forming an indent in the tubing that triggers an alarm when placed in the pump.".
 
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.
 
Manufacturer Narrative
H.6.Investigation summary: a complaint of kinked tubing was received from the customer.Photos were provided for investigation.In the photos, two different kinks could be seen in the tubing.One below the pinch clamp and the other below the drip chamber.The customer complaint was confirmed.A device history record review for model 2426-0007 lot number 22079245 was performed.The search showed that a total of 28,803 units in 1 lot number were built on 13jul2022.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to a physical sample not being sent, a definitive root caused could not be determined.Previous investigations have determined that improper coiling of the set can create the kinks seen.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.
 
Event Description
It was reported that 2 bd alaris¿ pump module smartsite¿ infusion sets were found with kinked tubing, one during use and one still in the packaging.The following information was provided by the initial reporter: "1.Below the safety clamp - where the pinch clamp is located below the safety clamp, an indent in the tubing is formed which triggers an alarm when placed in the pump.2.Below the drip chamber - as the tubing is packaged, the drip chamber is found bent forming an indent in the tubing that triggers an alarm when placed in the pump.".
 
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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 Key15830423
MDR Text Key307513102
Report Number9616066-2022-01781
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public(01)10885403227998
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 11/28/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot Number22079245
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2022
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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