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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 BURETTE SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS S.A. DE C.V. BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION BURETTE SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2441-0007
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/20/2023
Event Type  malfunction  
Event Description
It was reported that prior to use with bd alaris¿ pump module smartsite¿ infusion burette set the roller clamp was discovered to be missing.The following information was provided by the initial reporter: customer received a burette set here from staff, where they opened the package and found to have a missing roller clamp.Customer have the defective item for further investigation.
 
Manufacturer Narrative
B.3.Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple medical device types reported to be involved.The information for the additional device type is as follows: d.1 medical device type: lhi, d.2.Common device name: iv fluid transfer set.H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
Investigation summary: one sample of material number 2441-0007 was received for quality investigation.The customer complaint of clamp issue - roller clamp missing was verified by visual inspection.Evaluation of the sample submitted shows that the clamp that is supposed to be located after the pumping segment has not been added to the assembly.A device history record review for model 2441-0007 lot number 23015279 was performed.The search showed that a total of (b)(6) units in 1 lot number was built on 12jan2023.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause for the failure in this complaint is an assembler error.The proper work instruction was not followed, and the use of assembly fixture was not used causing for the assembly to be completed without the clamp.A quality alert was performed to reinforce the use of fixtures and the assembly properties.The manufacturing location was made aware of the issue and an investigation will be conducted to determine the necessary steps to correct this issue.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that prior to use with bd alaris¿ pump module smartsite¿ infusion burette set the roller clamp was discovered to be missing.The following information was provided by the initial reporter: customer received a burette set here from staff, where they opened the package and found to have a missing roller clamp.Customer have the defective item for further investigation.
 
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Brand Name
BD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION BURETTE 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 Key17303075
MDR Text Key318882105
Report Number9616066-2023-01410
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403235047
UDI-Public(01)10885403235047
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K022209
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 08/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2441-0007
Device Catalogue Number2441-0007
Device Lot Number23015279
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2023
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/04/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/10/2023
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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