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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 ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP MODULE SMARTSITE INFUSION SET INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2434-0007
Device Problems Complete Blockage (1094); Failure to Infuse (2340)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/08/2022
Event Type  malfunction  
Event Description
It was reported when using the bd alaris pump module smartsite infusion set, the device experienced flow issues due to being occluded/clogged. The following information was provided by the initial reporter. The customer stated: it was reported by the customer that the tubing beeps occluded and lipids are getting clogged. It was reported by the customer that the tubing beeps occluded and unable to free flow lipids through the tubing. It was reported by the customer that lipids were beeping occluded on the pump. No flow was noted despite squeezing the bag. It was reported by the customer that the lipid lines were beeping occluded. There was no flow while unclamped despite squeezing the bag. Lipid tubing continues to beep occluded, lipids are getting clogged in tubing. Lipid tubing beeps occluded and unable to free flow lipids through tubing. Lipids were beeping occluded on the pump. This rn flushed line, checked connections etc. Took tubing off of pump, no flow was noted despite squeezing bag. This rn was called to bedside because lipids line running through picc was beeping occluded.
 
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.
 
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Brand NameBD ALARIS PUMP MODULE SMARTSITE INFUSION SET
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
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13871105
MDR Text Key287808011
Report Number9616066-2022-00303
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203019682
UDI-Public07613203019682
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K944320
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 07/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2434-0007
Device Lot Number20096376
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2020
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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