Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXA ENGLEWOOD BAXA EXACTAMIX 2400 VALVE SET
  • 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
 

BAXA ENGLEWOOD BAXA EXACTAMIX 2400 VALVE SET Back to Search Results
Catalog Number 724
Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Patient Problem No Information (3190)
Event Date 06/12/2014
Event Type  malfunction  
Event Description
Baxa exactamix 2400 valve set - 24-port valve assembly found to have "leaking" number 4 port.Port had potassium acetate 2meq/ml 50 ml vial attached.Compounding technician noted bubbles entering the vial during the sterile water flush at the end of tpn compounding.The 6ml from the vial were unaccounted for.Tpn's compounded prior to the discovery were re-made for the neonatal population.Upon removal of the valve set the underside of port 4 was noted to be turned counterclockwise more so than the "normal" position.The side of the port facing the outside wall of the housing was noted to be pinched inward as well which could have happened during the initial set up process that day.Valve sets are changed at approximately 1100 each day.The time of discovery was approximately between 1400 and 1600.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BAXA EXACTAMIX 2400 VALVE SET
Type of Device
VALVE SET
Manufacturer (Section D)
BAXA ENGLEWOOD
MDR Report Key3893837
MDR Text Key4673581
Report NumberMW5036786
Device Sequence Number1
Product Code LHI
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Other
Type of Report Initial
Report Date 06/17/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/31/2016
Device Catalogue Number724
Device Lot Number790364
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received06/18/2014
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-