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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2260-0500
Device Problems Complete Blockage (1094); Inaccurate Flow Rate (1249)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/13/2021
Event Type  malfunction  
Manufacturer Narrative
Lot #: the batch number provided does not match the catalog number given. Medical device expiration date: unknown. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. Device manufacture date: unknown.
 
Event Description
It was reported when using the as lvp 20d low sorb, the device experienced flow issues and over infusion. The following information was provided by the initial reporter. The customer stated: it was reported by the customer that there overinfusion. I am emailing to report a potential over-infusion: event description: pump infused more mgso4 than it was programmed to. Patient effect: no harm reported.
 
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Brand NameAS LVP 20D LOW SORB
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
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12541054
MDR Text Key273602678
Report Number9616066-2021-52131
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K931173
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number2260-0500
Device Catalogue Number2260-0500
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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