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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 SS 0.2M; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D LOW SORB SS 0.2M; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 10010454-0006
Device Problem Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/27/2020
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 ss 0.2m tubing was primed and leaked saline before separating from the pump.The following information was provided by the initial reporter: "line primed with normal saline and leaking observed.Line fell apart at joint.".
 
Event Description
It was reported that the as lvp 20d low sorb ss 0.2m tubing was primed and leaked saline before separating from the pump.The following information was provided by the initial reporter: "line primed with normal saline and leaking observed.Line fell apart at join.".
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/15/2020.H.6.Investigation: one 10010454-0006 sample from lot 20066918 was received for investigation in opened packaging; residual fluid was present within the line.Further information provided by the customer indicates that the separation occurred from the filter immediately on priming the set.A visual inspection confirmed the customer's experience as the sample was received in two parts having separated at the tubing joint to the upper port of the in-line filter component.A closer inspection of the separated engagement identified small traces of residual solvent on the affected joint.A definitive root cause for the separation could not be determined in this instance; however it is possible that the tubing sleeve had been inadvertently expanded during the assembly process, which resulted in the tubing not correctly engaging onto the filter.This is a manual process and is likely to have occurred due to human error.A review of the production records for lot 20066918 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.H3 other text : see h.10.
 
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Brand Name
AS LVP 20D LOW SORB SS 0.2M
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 22244
MX  22244
MDR Report Key11089600
MDR Text Key250329089
Report Number9616066-2020-20670
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/29/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date06/24/2023
Device Catalogue Number10010454-0006
Device Lot Number20066918
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2020
Date Manufacturer Received01/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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