MAUDE Adverse Event Report: THERAKOS CELLEX

Device Problem Burst Container or Vessel (1074)

Event Date 02/25/2014

Event Type  No Answer Provided  

Event Description

Rupture of the tubing on therakos cellex photopheresis device with loss of one unit of blood into the machine.The pt has sezary syndrome, the leukemic form of cutaneous t-cell lymphoma and was nearing the completion of treatment at which time the line exploded leading to the loss of all blood in the centrifuge system into the machine.The blood could not be returned to the pt.Had they been significantly anemic or hypotensive, this problem may have been life threatening.During the past 12 months, our unit has recorded numerous shut down of the device requiring transfer to an alternative device (transfer to the xts device).Diagnosis or reason for use: to treat the leukemic phase of t-cell lymphoma.

• Brand Name: CELLEX
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS
• MDR Report Key: 3664712
• MDR Text Key: 4346952
• Report Number: MW5034817
• 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: Physician
• Type of Report: Initial
• Report Date: 02/27/2014

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/04/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 54 YR