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: THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
  • 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
 

THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL Back to Search Results
Catalog Number CLXUSA
Device Problems Burst Container or Vessel (1074); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/13/2016
Event Type  malfunction  
Event Description
Multiple air detected alarms during collection of blood.Blue lumen of hickman central line used for collection.ࠌine was flushed twice.No system pressure alarm but pressure dome burst with blood leak on machine deck.Therakos clinical support notified and blood was not returned to patient due to probable contamination.Patient's vss and she denied sob and dizziness.Pa notified.Patient instructed to call bone marrow transplant (bmt) team if symptomatic at home.She was also instructed to have a repeat cbcp lab draw before next ecp treatment this week.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CELLEX
Type of Device
SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
Manufacturer (Section D)
THERAKOS, INC.
10 north high street
suite 300
west chester PA 19380
MDR Report Key6046601
MDR Text Key58083140
Report Number6046601
Device Sequence Number1
Product Code LNR
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 10/06/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberCLXUSA
Device Lot NumberE315/457
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/06/2016
Event Location Hospital
Date Report to Manufacturer10/06/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/21/2016
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age33 YR
-
-