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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 2420-0007
Device Problems Leak/Splash (1354); Material Puncture/Hole (1504); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer. The customer complaint of component damage - no leak could not be verified due to the product not being returned for failure investigation. A device history record review for model 2420-0007 lot number 21035087 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 01mar2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. 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.
 
Event Description
It was reported that there was a hole in the bd alaris¿ pump module smartsite¿ infusion set tubing. The following information was provided by the initial reporter: "there is a hole in tubing. ".
 
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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
MDR Report Key12600816
MDR Text Key275930956
Report Number9616066-2021-52192
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021020
UDI-Public37613203021020
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 09/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number21035087
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/24/2021
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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