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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 Defective Component (2292); Separation Failure (2547)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/17/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown. Device manufacture date: unknown. Investigation summary: no product or photo was returned by the customer. The customer complaint of silicone segment separating could not be verified due to the product not being returned for failure investigation. According to the report, the root cause is most likely manufacturing issue with the retainer ring that goes on over top of the silicon tubing. There is no record of the retainer ring being present or not, and without the sample investigation the root cause cannot be determined. The customer had not used the sample, and loaded the tubing correctly, ruling out user error. A device history record review could not be performed on model 2420-0007 because a valid lot number was not provided by the customer. 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 the bd alaris¿ pump module smartsite¿ infusion set silicone segment separated from the blue tip. The following information was provided by the initial reporter: "anesthesiologist, told me she had a pump set, 2420-0007, malfunctioned. Shortly after she took it out of the package the silicone segment separated from the blue tip. She did not stretch the silicone and she loaded it correctly in the pump - top to bottom. ".
 
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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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12482010
MDR Text Key271898350
Report Number9616066-2021-52055
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 other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/23/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/19/2021
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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