MAUDE Adverse Event Report: THERAKOS, INC THERAKOS CELLEX; THERAKOS CELLEX PHOTOPHERESIS PROCEDURE KITS

Catalog Number CLXUSA

Device Problems Fluid/Blood Leak (1250); Material Separation (1562); Device Dislodged or Dislocated (2923)

Patient Problem Blood Loss (2597)

Event Date 06/02/2014

Event Type  Injury  

Event Description

While performing a photopheresis procedure, at 21 minutes run-time, the pressure system done, located on the centrifuge system pressure sensor, dislodged from the sensor.The internal membrane separated from the pressure dome which resulted in a blood leak and subsequent blood loss to the patient.

• Brand Name: THERAKOS CELLEX
• Type of Device: THERAKOS CELLEX PHOTOPHERESIS PROCEDURE KITS
• Manufacturer (Section D): THERAKOS, INC; 1001 us highway 202; raritan NJ 08869
• MDR Report Key: 3866723
• MDR Text Key: 16596523
• Report Number: MW5036503
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 06/02/2014

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 Date: 04/01/2016
• Device Catalogue Number: CLXUSA
• Device Lot Number: C316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/02/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR
• Patient Weight: 71