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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP, TEXIUM & HANGER V/NV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEC 20DP, TEXIUM & HANGER V/NV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 40000-07T
Device Problems Separation Failure (2547); Separation Problem (4043)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
It was reported 2 bd sec 20dp, texium & hanger v/nv experienced separation with no leakage the following information was provided by the initial reporter: separation other component- no leak, when tubing removed from package it was reported that the tubing came apart when removing tubing from packages.
 
Manufacturer Narrative
A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.Medical device expiration date: unknown.Device manufacture date: unknown.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 11/22/2021.H.6.Investigation: two samples were submitted for quality investigation.The customer complaint of separation - no leak, was verified by visual inspection.The samples submitted were visually examined and the separation of the secondary sets were noted at the outlet of the drip chambers to the tubing.Further evaluation was conducted under magnification and there is no evidence of solvent on the joining components.A device history record review for model 40000-07t lot number 20095693 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 for the failure seen in this complaint is that there is a lack of solvent between the drip chamber outlet and the connecting tubing, therefore causing the secondary set to easily separate at that location.This is an issue caused during the manufacturing of the secondary set.Capa#1521069 was initiated.A complaint history check was performed and this is the 7th related complaint reported with the defect/condition of separation other component - no leak with lot #20095693 regarding item #40000-07t.H3 other text : see h.10.
 
Event Description
It was reported 2 bd sec 20dp, texium & hanger v/nv experienced separation with no leakage the following information was provided by the initial reporter: separation other component- no leak, when tubing removed from package it was reported that the tubing came apart when removing tubing from packages.
 
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Brand Name
SEC 20DP, TEXIUM & HANGER V/NV
Type of Device
INTRAVASCULAR 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 Key12980256
MDR Text Key285339847
Report Number9616066-2021-52575
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403225626
UDI-Public50885403225626
Combination Product (y/n)Y
Reporter Country CodeCA
PMA/PMN Number
K790582
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number40000-07T
Device Catalogue Number40000-07T
Device Lot Number20095693
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/22/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/05/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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