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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 2SS CV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D 2SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0007
Device Problems Complete Blockage (1094); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
Event Type  malfunction  
Manufacturer Narrative
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 that the as lvp 20d 2ss cv experienced flow issues and was clogged/blocked/occluded.The following information was provided by the initial reporter: material no: 2420-0007, batch no: unknown.I kept titrating the levophed to over 0.5 with the doctors at the bedside multiple times with no noticeable improvement in patients bp.Labs were sent and patient started on high dose steroids.Vasopressin was ordered in addition to the levophed.Before i hung the vaso i realized the pump was not actually delivering any levophed at all even though the line was primed and loaded correctly and the pump thought it was delivering it and gave no errors at all.Upon further inspection the tubing inside the channel was flat and the internal pump mechanism did not seem to be working correctly while the pump seemed to be infusing with no problems and no errors/alarms.Levophed was disconnected and no difference to patients bp was noted.Charge rn, resident, and fellow notified.This set of tubing was dated and hung on 1-22 and the bottle of levophed had more than 250cc of volume in it where a new bottle has 250.The patient couldn't have gotten any levophed when they originally hung the container 3 days prior either.
 
Event Description
It was reported that the as lvp 20d 2ss cv experienced flow issues and was clogged/blocked/occluded.The following information was provided by the initial reporter: material no: 2420-0007, batch no: unknown.I kept titrating the levophed to over 0.5 with the doctors at the bedside multiple times with no noticeable improvement in patients bp.Labs were sent and patient started on high dose steroids.Vasopressin was ordered in addition to the levophed.Before i hung the vaso i realized the pump was not actually delivering any levophed at all even though the line was primed and loaded correctly and the pump thought it was delivering it and gave no errors at all.Upon further inspection the tubing inside the channel was flat and the internal pump mechanism did not seem to be working correctly while the pump seemed to be infusing with no problems and no errors/alarms.Levophed was disconnected and no difference to patients bp was noted.Charge rn, resident, and fellow notified.This set of tubing was dated and hung on 1-22 and the bottle of levophed had more than 250cc of volume in it where a new bottle has 250.The patient couldn't have gotten any levophed when they originally hung the container 3 days prior either.
 
Manufacturer Narrative
This complaint has been identified as a duplicate of mfr report #: 2243072-2021-00573.This complaint and the initial mdr, (mfr report # 9616066-2021-50632), can therefore be disregarded.
 
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Brand Name
AS LVP 20D 2SS CV
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
MDR Report Key11600093
MDR Text Key266666414
Report Number9616066-2021-50632
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 04/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2420-0007
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2021
Date Manufacturer Received04/01/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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