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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET
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SISTEMAS MEDICOS ALARIS, S.A. DE C. ALARIS PUMP MODULE SMARTSITE INFUSION SET; INTRAVASCULAR ADMINISTRATION SET Back to Search Results
Catalog Number 2420-0500
Device Problems Component Missing (2306); Free or Unrestricted Flow (2945)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/26/2020
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.
 
Event Description
It was reported that the alaris pump module smartsite infusion set experienced a missing component: roller clamp.The following information was provided by the initial reporter: went to prime the "bdalaris pump infusion set" and the tubing was missing a roller clamp.So, i grabbed another one and that tubing was missing a luer lock at the end.Lot is (10) 20043249 for both packages of tubing.
 
Manufacturer Narrative
Due to no photo or sample being received, the customer's complaint of misassembly / missing roller clamp could not be verified at this time.A device history record review for model 2420-0500 lot number 20043249 was performed.The search showed that a total of 34,563 units in 1 lot number was built on (b)(6) 2020.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.
 
Event Description
It was reported that the alaris pump module smartsite infusion set experienced a missing component: roller clamp.The following information was provided by the initial reporter: went to prime the "bdalaris pump infusion set" and the tubing was missing a roller clamp.So, i grabbed another one and that tubing was missing a luer lock at the end.Lot is (10) 20043249 for both packages of tubing.
 
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Brand Name
ALARIS PUMP MODULE SMARTSITE INFUSION SET
Type of Device
INTRAVASCULAR ADMINISTRATION SET
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.
blvd. insurgentes 20351
tijuana, null 22244
MX  22244
MDR Report Key10318940
MDR Text Key200248120
Report Number9616066-2020-02296
Device Sequence Number1
Product Code FPA
UDI-Device Identifier07613203012430
UDI-Public7613203012430
Combination Product (y/n)N
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Type of Report Initial,Followup
Report Date 06/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/11/2023
Device Catalogue Number2420-0500
Device Lot Number20043249
Was Device Available for Evaluation? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
20200526; 20200526; 20200526
Patient Outcome(s) Other;
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