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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 DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 3SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2426-0500
Device Problems Leak/Splash (1354); Free or Unrestricted Flow (2945)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/02/2020
Event Type  malfunction  
Manufacturer Narrative
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.(b)(4).
 
Event Description
It was reported that air pockets were found in the as lvp 20d dehp 3ss cv tubing while priming it.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "clinicians found 4 inches long air pockets about 6 inches away from entering the patient.This was not used on a pt.The issue was realized when they were priming the tubing outside of the pt¿s room before administering prbcs.It was free hanging trauma blood tubing.No programming involved.".
 
Manufacturer Narrative
Investigation summary: a complaint of air in line was received from the customer.No product or photo was returned by the customer.The customer complaint of air in line could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on model: 2426-0500 because a lot number was not provided by the customer.The root cause of this failure was not identified as no product was returned.
 
Event Description
It was reported that air pockets were found in the as lvp 20d dehp 3ss cv tubing while priming it.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "clinicians found 4 inches long air pockets about 6 inches away from entering the patient.This was not used on a pt.The issue was realized when they were priming the tubing outside of the pt¿s room before administering prbcs.It was free hanging trauma blood tubing.No programming involved.".
 
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Brand Name
AS LVP 20D DEHP 3SS 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 22244
MX  22244
MDR Report Key11096050
MDR Text Key250334493
Report Number9616066-2020-20692
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203021006
UDI-Public37613203021006
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 01/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2426-0500
Device Catalogue Number2426-0500
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received01/13/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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