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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 Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
Manufacturer Narrative
Device expiration date: unknown. Device manufacture date: unknown. Investigation summary: a complaint of flow issues causing medication to not be infused was received from the customer. No product or photo was returned by the customer. The customer complaint of flow issues could not be verified due to the product not being returned for failure investigation. A device history record review could not be performed on model 2426-0007 because the lot number is unknown. Due to no sample being received, an investigation could not be performed, and a root cause could not be determined. This incident has been added to our database of reported incidents. Our business team regularly reviews the collected data for identification of emerging trends. Due to no sample being received, an investigation could not be performed, and a root cause could not be determined. No product will be returned per customer. No investigation was performed.
 
Event Description
It was reported that the bd alaris pump module smartsite infusion set experienced flow issues. The following information was provided by the initial reporter: iv pump channel displayed that infusion was complete and did not alarm any further issues. Iv bag of cisplatin noted to still be completely full. Pt did not receive the treatment within that hour in the chair. All connections and tubing checked by multiple nurses with no noticeable issues. Fluids and tubing changed and infusion reinitiated.
 
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Brand NameBD ALARIS PUMP MODULE SMARTSITE INFUSION 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 Key14162575
MDR Text Key289697546
Report Number9616066-2022-00447
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public10885403227998
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
Report Date 04/07/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2426-0007
Device Catalogue Number2426-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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