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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 Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/28/2022
Event Type  malfunction  
Event Description
It was reported while using bd alaris pump module smartsite infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 1 ea, tubing leaking due to cut in tubing, package has no cuts.What was the date of event? (b)(6) 2022.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 24-oct-2022.H6: investigation summary one sample of material number 2426-0007 was submitted for quality investigation.The customer complaint of tubing defective/damaged was verified by visual inspection.Evaluation of the sample shows that there is a smooth cut in the tubing allowing for leakage to occur from the infusion set.The cut is located in the tubing after the drip chamber.A device history record review for model 2426-0007 lot number 22069521 was performed.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 issue seen in this complaint is an issue with the handling of the tubing at that manufacturing level.Due to the cut in the tubing appearing smooth, the tubing was most likely cut by a sharp edge.The manufacturing location had conducted an investigation of the assembly process and environment and identified the use of inappropriate sharp equipment for the removal of the roll packaging.Updates to the handling process have been incorporated into the manufacturing process to eliminate the issue.
 
Event Description
It was reported while using bd alaris pump module smartsite infusion set leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter: 1 ea, tubing leaking due to cut in tubing, package has no cuts.What was the date of event? 9/28/2022.
 
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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 Key15728833
MDR Text Key307507351
Report Number9616066-2022-01672
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 02/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
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 Number22069521
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/11/2022
Initial Date FDA Received11/04/2022
Supplement Dates Manufacturer Received02/02/2023
Supplement Dates FDA Received02/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2022
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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