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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 MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S); INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number MFS102
Device Problem Failure to Deliver (2338)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/30/2023
Event Type  malfunction  
Event Description
It was reported that during use with bd maxguard flow controller administration set with needleless y-site(s) device was occluded.There was no report of patient impact.The following information was provided by the initial reporter: situation: fluid bag is spiked; the flow controller is set to open and the line primes without issue.When the controller is set to the rate decide there is no flow.Occurred 7 times in last tow days.Rns moved to another device or used alaris pump.Background: the device is designed to be used in open mode to prime the tubing and then the rn can set the rate of flow per ordered rate.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary: no sample ( mat # mfs102) received by the customer.Photos representation was provided for the complaint.It was reported by the customer that the product is having flow issues.However the failure could not be verified in the photos.A device history record review for model mfs102 and lot number 22029883 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this lot.Due to no sample being received a root cause could not be determined.H3 other text : see h10.
 
Event Description
It was reported that during use with bd maxguard flow controller administration set with needleless y-site(s) device was occluded.There was no report of patient impact.The following information was provided by the initial reporter: situation: fluid bag is spiked; the flow controller is set to open and the line primes without issue.When the controller is set to the rate decide there is no flow.Occurred 7 times in last tow days.Rns moved to another device or used alaris pump.Background: the device is designed to be used in open mode to prime the tubing and then the rn can set the rate of flow per ordered rate.
 
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Brand Name
BD MAXGUARD FLOW CONTROLLER ADMINISTRATION SET WITH NEEDLELESS Y-SITE(S)
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
8448235433
MDR Report Key16432427
MDR Text Key310245560
Report Number9616066-2023-00253
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403236334
UDI-Public(01)10885403236334
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K051499
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,Followup
Report Date 04/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMFS102
Device Catalogue NumberMFS102
Device Lot Number22029883
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/05/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/28/2022
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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