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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7 INCH MIC EXT SET W/1.2MF INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 7 INCH MIC EXT SET W/1.2MF INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 20129E
Device Problems Backflow (1064); Complete Blockage (1094); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/03/2021
Event Type  malfunction  
Manufacturer Narrative
Fda notified?: the initial reporter also notified the fda via medwatch # (b)(4). Investigation summary: the customer reported blood was backing up into the line, and returned one used sample of the provided material number and lot number. The complaint of backflow was verified, and the filter appeared to be occluded while still full of lipids. The filter could not be tested with water, as the female luer was separated from the tubing upon being received, which was not reported. The root cause for the back flow is most likely the leak reported within the filter, or even the leak/separation at the female luer. When administering different nutrients through filtered sets, the sets must be switched in shorter intervals than those of regular soluble medications or saline solutions. Infusions using tpn will shorten the period in which set is to be active with patient. When lipids are administered, the set should be swapped every 12 hrs. The root cause for the complaint could be the long interval of tpn infusion. A device history record review for the provided model and lot number was performed. There were no quality notifications issued for the failure mode reported by the customer during the production build of this set. The root cause is unknown as the tubing was compromised, and it is unknown how long the infusion lasted. 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 7 inch mic ext set w/1. 2mf had back flow, flow issues, and component separation causing leakage. The following information was provided by the initial reporter: "i changed my uvc double lumen fluids i then got baby up for mom to hold. I noticed blood backing up into uvc line i then noticed lipids on the mother's leg. I quickly realized the magic filter had come apart in the middle. ".
 
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Brand Name7 INCH MIC EXT SET W/1.2MF
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 Key12615920
MDR Text Key275936839
Report Number9616066-2021-52203
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K790108
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/15/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20129E
Device Catalogue Number20129E
Device Lot Number21035916
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2021
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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