• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0007
Device Problem Free or Unrestricted Flow (2945)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/26/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete. Upon completion, a supplemental report will be filed. (b)(4).
 
Event Description
It was reported that as lvp 20d 2ss cv had a check valve malfunction. The following information was provided by the initial reporter: material no: 2420-0007, batch no: 20075382, it was reported that once line was placed into the pump, the primary bag of ns continued to fill the systemic therapy bag with ns. Verbatim: date of incident (yyyy-mm-dd): (b)(6) 2020. Type of incident/problem: malfunction - during or after use. Level of harm: no effect - did not reach patient - detected before use or does not touch person during use. Ahs optional report to (b)(6)): yes. Incident details: infusion nurse was administering chemotherapy to patient. Systemic agent was attached to the y-site port below the drip chamber and back flow priming of secondary tubing was complete. Once line was placed into the alaris pump the primary bag of ns continued to fill the systemic therapy bag with ns. Nurse noticed immediately and clamped secondary to stop back flow from occurring. With back flow continuing the systemic bag would fill and dilute drug further therefore patient would receive more fluids that are not required. Secondary tubing removed and placed on new line for administration. Who was affected? no person affected. Frequency of problem: recurring.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAS LVP 20D 2SS 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 Key11101596
MDR Text Key246119989
Report Number9616066-2020-20698
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021020
UDI-Public37613203021020
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 01/05/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2420-0007
Device Catalogue Number2420-0007
Device Lot Number20075382
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 Received01/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/02/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-