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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 Problems Separation Failure (2547); Defective Device (2588)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/25/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: one 2441-0007 sample was received without packaging, however the customer indicated that the complaint sample was from lot 21075117. Residual fluid was present in the line. The sample was subjected to pressure testing, which confirmed the customer's experience; leakage was observed from a hole in the silicone tubing at the upper pumping segment tubing connector. The details of this feedback were forwarded to the manufacturing site for investigation. They confirmed that the observed damage is consistent with the component being subjected to an external force; however a review of the manufacturing and packaging process did not identify any potential sources which could cause or contribute to damage of this nature. A review of the production records for lot 21075117 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature. The quality team at the manufacturing site has been informed of this report in order to be aware of the reported feedback during future production of this product. A review of the customer feedback database indicates that this is a rare occurrence with this customer being the only customer to provide this type of feedback against the 2441-0007 product in the past 12 months.
 
Event Description
It was reported that 1 bd alaris¿ pump module smartsite¿ infusion burette set had a tear in the line, and another set's line broke off completely. The following information was provided by the initial reporter: "we have received another 2 faulty lines. 1 of them has a small tear and the other line has completely broke off, this is from a different batch (10) 21075117. " " was this product issue during use on a patient or before in the set up phase? the fault occurred at setup. Was a patient injured? was a staff member injured? no patient was injured. What fluids/drugs were being administered? uncertain on fluid used. Did these two sets come from the same clinical area or from two separate clinical areas? eg er as previous two sets you had provided information on yes both sets came from er. We have also asked biomed to check through the pumps on ec to make sure there is no issue with the pumps there. ".
 
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Brand NameBD ALARIS¿ PUMP MODULE SMARTSITE¿ INFUSION BURETTE SET
Type of DeviceINTRAVASCULAR 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 Key13053872
MDR Text Key286454722
Report Number9616066-2021-52628
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K944320
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
Report Date 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2441-0007
Device Catalogue Number2441-0007
Device Lot Number21075117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/25/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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