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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
Catalog Number 2420-0007
Device Problems Backflow (1064); Leak/Splash (1354); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/29/2021
Event Type  malfunction  
Manufacturer Narrative
A lot number was not provided, however, an empty package was received. The information for the empty package is as follows: medical device lot #: 21046236, medical device expiration date: 04/17/2024, device manufacture date: 04/17/2021. Investigation summary: one sample was returned for investigation. Through visual inspection, the customer complaint was confirmed. The male luer was separated from the rest of the set. No solvent was observed on the tubing that connects to the male luer. No other damages or defects were observed on the set. The root cause for the separation is a lack of solvent at the connection site of the tubing and male luer. A device history record review for model 2420-0007, lot number 21046236 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 17apr2021. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. 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 while using bd alaris¿ pump module smartsite¿ infusion set, the tubing separated, which caused leakage and blood backflow. This has occurred once and no harm/injury reported. The following information was provided by the initial reporter: i received a report of a tubing separating during medication administration. Separated during usage ¿ medication and blood went on floor. Had to remove and replace. From email: tubing with medication infusing through pump was luer locked into primary line at closest port to patient. Tubing came apart leaving the tubing separated from the luer lock that remained in place. Medication was found infusing on the floor and blood was back flushing into tubing. Malfunctioning tubing has been bagged and saved for event. Patient line was flushed and continues to be patent.
 
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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 Key13122550
MDR Text Key286116911
Report Number9616066-2021-52663
Device Sequence Number1
Product Code FPA
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 User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/07/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2420-0007
Device Lot Number21046236
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/06/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/17/2021
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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