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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 2SS CV; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C.V. AS LVP 20D DEHP 2SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Model Number 2420-0500
Device Problem Leak/Splash (1354)
Patient Problems Exposure to Body Fluids (1745); Underdose (2542)
Event Date 08/26/2020
Event Type  Injury  
Manufacturer Narrative
(b)(4).Investigation summary: two photos displaying the separation of tubing from a smartsite was received from the customer.The customer complaint that tubing became disconnected was verified.However a root cause could not be determined since the product was not returned for failure investigation.A device history record review for model 2420-0500 lot number 20063048 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 02jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Investigation conclusion: two photos displaying the separation of tubing from a smartsite was received from the customer.The customer complaint that tubing became disconnected was verified.Root cause description: however a root cause could not be determined since the product was not returned for failure investigation.Rationale: this incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the as lvp 20d dehp 2ss cv disconnected during use and causing a mixture of blood and saline to expel into the air, "contaminating" the patient and rn.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: describe the event or problem: "middle aged female with the history of hypertension disorder, deep vein thrombosis, anemia and systemic lupus.While receiving 1 unit of packed red blood cells m the outpatient infusion area, the pump paused.Blood line of dual line tubing clamped, saline line opened.Started pump back up at a rate of 200 and immediately the tubing became disconnected directly below the drip chamber causing saline/blood mixture to be expelled into the air contaminating both the patient and rn.This is the second time this tubing has come apart in the same place.".
 
Manufacturer Narrative
Investigation summary: two photos displaying the separation of tubing from a smartsite was received from the customer.The customer complaint that tubing became disconnected was verified.However a root cause could not be determined since the product was not returned for failure investigation.A device history record review for model 2420-0500 lot number 20063048 was performed.The search showed that a total of 34,583 units in 1 lot number was built on 02jun2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported that the as lvp 20d dehp 2ss cv disconnected during use and causing a mixture of blood and saline to expel into the air, "contaminating" the patient and rn.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: describe the event or problem: "middle aged female with the history of hypertension disorder, deep vein thrombosis, anemia and systemic lupus.While receiving 1 unit of packed red blood cells m the outpatient infusion area, the pump paused.Blood line of dual line tubing clamped, saline line opened.Started pump back up at a rate of 200 and immediately the tubing became disconnected directly below the drip chamber causing saline/blood mixture to be expelled into the air contaminating both the patient and rn.This is the second time this tubing has come apart in the same place.".
 
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Brand Name
AS LVP 20D DEHP 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 22244
MX  22244
MDR Report Key10788236
MDR Text Key214820874
Report Number9616066-2020-20243
Device Sequence Number1
Product Code FPA
UDI-Device Identifier37613203012448
UDI-Public37613203012448
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2023
Device Model Number2420-0500
Device Catalogue Number2420-0500
Device Lot Number20063048
Was Device Available for Evaluation? No
Date Manufacturer Received11/23/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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