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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 3SS CV INTRAVASCULAR ADMINISTRATION SET

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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB 3SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 24600-0007
Device Problem Complete Blockage (1094)
Patient Problems Underdose (2542); Insufficient Information (4580)
Event Date 12/02/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that the as lvp 20d low sorb 3ss cv had flow issues when infusing taxol, leaving "140 cc" left in the bag. This complaint was created to capture the 1st of 2 related incidents. The following information was provided by the initial reporter: "this was an under infusion incident- once chemo (taxol) infusion was completed there was still 140 cc left over of chemo in the bag. (total volume 608cc)".
 
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Brand NameAS LVP 20D LOW SORB 3SS CV
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 22244
MX 22244
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana 22244
MX 22244
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key11128898
MDR Text Key240992027
Report Number9616066-2020-20729
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
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,Followup
Report Date 03/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number24600-0007
Device Catalogue Number24600-0007
Device Lot Number20066468
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/14/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/15/2020
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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