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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H.10; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. SEE H.10; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number MZ9329
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/28/2022
Event Type  malfunction  
Event Description
It was reported that the bd maxzero¿ extension set, microbore, bifuse, 2 removable maxzero¿ needle-free connectors experienced flow issue.The following information was provided by the initial reporter: the 1.2 micron filter for lipids which when stopped for medication administration and restarted the lipids back up into the tpn.
 
Manufacturer Narrative
A device evaluation is anticipated but not yet began.Upon completion of the investigation a supplemental report will be filled.Medical device brand name: bd maxzero¿ extension set, microbore, bifuse, 2 removable maxzero¿ needle-free connectors.
 
Manufacturer Narrative
H6: investigation summary: one maxzero extension set (model #mz9329), a primary set, a maxzero (2-port connector) set, and a 20 ml syringe were returned by the customer.It was reported that the lipids, which when stopped for medication administration and restarted, the lipids back up into the tpn.The returned sets and syringe were examined for defects and abnormalities.No defects or abnormalities were observed.The primary set was received with an attached bag.The syringe was returned filled with lipids, and connected to the maxzero extension set.The maxzero 2-port connector was connected to both ends of the primary and syringe lines.For the primary line, an infusion was completed using the bd alaris pump and pump module at 125 ml/hr with a vtbi of 125 ml.For the syringe line, an infusion was completed using the bd alaris pump and syringe pump module at 10 ml/hr with a vtbi of 10 ml.Each line was paused halfway through the infusion to see if any back flow would occur.No back flow of lipids was observed.The infusions were completed without issue.No back flow of lipids was observed.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model mz9329 lot number 21095956 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 05oct2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
 
Event Description
It was reported that the bd maxzero¿ extension set, microbore, bifuse, 2 removable maxzero¿ needle-free connectors experienced flow issue.The following information was provided by the initial reporter: the 1.2 micron filter for lipids which when stopped for medication administration and restarted the lipids back up into the tpn.
 
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Brand Name
SEE H.10
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 Key14435073
MDR Text Key292020359
Report Number9616066-2022-00623
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K193088
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 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/19/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberMZ9329
Device Lot Number21095956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/10/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2021
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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