• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP SET WITH CHECK VALVE 2 NEEDLE FREE PORTS INTRAVASCULAR CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD ALARIS PUMP SET WITH CHECK VALVE 2 NEEDLE FREE PORTS INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 2420-0007
Device Problems Backflow (1064); Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/11/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: no product or photo was returned by the customer. The customer complaint of separation other component - leak 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 21065859 was performed. The search showed that a total of (b)(4) units in 1 lot number was built on 14jun2021. 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 when using the bd alaris pump set with check valve 2 needle free ports, the device experienced blood backflow- during the infusion. The following information was provided by the initial reporter. The customer stated: level of harm: no apparent harm. Writer connected pt to iv tubing and line pulling blood from iv site, pt exsanguinating from pump infusion set tubing at the y-site closest to iv. Ns also pouring out. Close call/near miss as this is potential for hazard with chemo spills.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD ALARIS PUMP SET WITH CHECK VALVE 2 NEEDLE FREE PORTS
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer (Section G)
SISTEMAS MEDICOS ALARIS, S.A. DE C.V.
blvd. insurgentes no. 20351
parque industrial el florido
tijuana
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13004389
MDR Text Key285350810
Report Number9616066-2021-52589
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K944320
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/12/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2420-0007
Device Lot Number21065859
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/21/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-