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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AS LVP 20D 3SS CV; INTRAVASCULAR ADMINISTRATION SET
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AS LVP 20D 3SS CV; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2426-0007
Device Problem Improper Flow or Infusion (2954)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/16/2021
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.
 
Event Description
It was reported that as lvp 20d 3ss cv had back flow.The following information was provided by the initial reporter: it was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.Verbatim: date of occurrence: (b)(6) 2021.Patient's iv infusion was set up as a secondary infusion.Primary tubing was primed with ns and secondary tubing was connected to ordered medication.Once infusion was started and tubing was unclamped, this nurse noted secondary infusion was back flowing into primary tubing's chamber instead of infusing into patient.All tubing was clamped before primary tubing's chamber had filled, preventing medication from completely back-filling into ns bag.Requested second nurse to assist in trouble-shooting.Unable to determine cause of improper flow.
 
Event Description
It was reported that as lvp 20d 3ss cv had back flow.The following information was provided by the initial reporter: it was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.Verbatim: date of occurrence: (b)(6) 2021.Patient's iv infusion was set up as a secondary infusion.Primary tubing was primed with ns and secondary tubing was connected to ordered medication.Once infusion was started and tubing was unclamped, this nurse noted secondary infusion was back flowing into primary tubing's chamber instead of infusing into patient.All tubing was clamped before primary tubing's chamber had filled, preventing medication from completely back-filling into ns bag.Requested second nurse to assist in trouble-shooting.Unable to determine cause of improper flow.
 
Manufacturer Narrative
H6: investigation summary: no product or photo was returned by the customer.It was reported by the customer that the secondary infusion was back flowing into primary tubing's chamber.The customer complaint could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 21029010 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11feb2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A device history record review for model 11448964 lot number 21039546 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 11mar2021.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
AS LVP 20D 3SS CV
Type of Device
INTRAVASCULAR ADMINISTRATION SET
MDR Report Key12337675
MDR Text Key267114173
Report Number9616066-2021-51823
Device Sequence Number1
Product Code FPA
UDI-Device Identifier10885403227998
UDI-Public10885403227998
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 09/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2024
Device Catalogue Number2426-0007
Device Lot Number21029010
Was Device Available for Evaluation? No
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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