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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. GEM V/NV 20DP DEHP FREE; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 10942011
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/18/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: one photo of primary set, model 10942011, was received by the customer for investigation.Upon visual inspection, it could be observed that there was a significant amount of air in the tubing.No other defects were observed.The customer's complaint that there is air/ bubbles in the tubing when primed was verified.A device history record review for model 10942011 lot number 20116952 was performed.The search showed that a total of 11,523 units in 1 lot number was built on 27nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Since no physical sample was received, a full 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.Investigation conclusion: since no physical sample was received, a full investigation could not be performed and a root cause could not be determined.
 
Event Description
It was reported that the gem v/nv 20dp dehp free experienced air bubbles/air in line.The following information was provided by the initial reporter: material #: 10942011.Batch/ lot #: 20116952.Rn noticed that bd alaris pump infusion set develops air in tubing when primed and increase in air bubbles.Not all the air comes out when attempt to flick at it, and even when primed further, there seems to be more air.The tubing seems different than what we used to use, and below a joint in the tubing is where the air and bubbles happen.Air in line.Rn states when priming, finds air under the connection.Even with flicking, the air does not fully dissipate.There also seems to be in increase in small air bubbles that cause the pump to alarm more often.
 
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Brand Name
GEM V/NV 20DP DEHP FREE
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12013309
MDR Text Key263492639
Report Number9616066-2021-51325
Device Sequence Number1
Product Code FPA
UDI-Device Identifier50885403232402
UDI-Public50885403232402
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K931173
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 06/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/27/2023
Device Model Number10942011
Device Catalogue Number10942011
Device Lot Number20116952
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2021
Initial Date FDA Received06/16/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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