MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PROCEDURAL KIT

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Fitting Problem (2183); Torn Material (3024)

Patient Problem Blood Loss (2597)

Event Date 03/19/2014

Event Type  malfunction  

Event Description

While performing a photopheresis procedure and approx 1 liters into the treatment a blood leak was detected into the centrifuge compartment.The procedure paused immediately.Upon inspection of the tubing, it was noted a tear approx 1 cm on the centrifuge tubing.It was also noted that the tubing was not tight fitting into the centrifuge bowl arm brackets.The procedure was halted due to contamination.Blood loss of approximately 140 ml.Patient asymptomatic and v.S.S.Patient was discharged home.The kit was sent to the manufacturer for evaluation.

• Brand Name: THERAKOS CELLEX PROCEDURAL KIT
• Type of Device: THERAKOS CELLEX PROCEDURAL KIT
• Manufacturer (Section D): THERAKOS INC.
• MDR Report Key: 3815393
• MDR Text Key: 20109806
• Report Number: MW5036113
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

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 Date: 01/01/2016
• Device Catalogue Number: CLXUSA
• Device Lot Number: C303
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/09/2014
• Patient Sequence Number: 1
• Patient Age: 36 YR