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/MALLINCKRODT PHARMACEUTICALS CELLEX PROCEDURAL KIT
  • 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/MALLINCKRODT PHARMACEUTICALS CELLEX PROCEDURAL KIT Back to Search Results
Lot Number D372
Device Problems Fracture (1260); Leak/Splash (1354); Defective Component (2292)
Patient Problems Anemia (1706); Anxiety (2328)
Event Date 03/04/2016
Event Type  Injury  
Event Description
A (b)(6) patient undergoing extracorporeal photopheresis (ecp) treatment.During the procedure, the rn heard sound similar to something coming loose followed immediately by an alarm indicated a centrifuge leak.Rn immediately clamped both lines of patient's central venous catheter.Another alarm occurred, "system pressure alarm." rn and physician noted the tubing filled with patient's blood had leaked, resulting in blood splattering throughout centrifuge chamber.Upon further inspection, drive tube noted to have a crack present.Another area of drive tube was noted to be irregular in appearance.Patient impact: procedure aborted, patient unable to receive ecp treatment.Blood loss of 400-450 cc requiring transfusion.Patient and parent anxiety.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CELLEX PROCEDURAL KIT
Type of Device
CELLEX PROCEDURAL KIT
Manufacturer (Section D)
THERAKOS/MALLINCKRODT PHARMACEUTICALS
west chester PA
MDR Report Key5546992
MDR Text Key41989948
Report Number5546992
Device Sequence Number1
Product Code LNR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/15/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/01/2017
Device Lot NumberD372
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/07/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/15/2016
Distributor Facility Aware Date03/04/2016
Event Location Hospital
Date Report to Manufacturer03/04/2016
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age12 YR
-
-