MAUDE Adverse Event Report: THERAKOS, INC. CELLEX; SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL

Model Number CELLEX

Device Problem Device Inoperable (1663)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/30/2014

Event Type  malfunction  

Event Description

The pediatric patient has a history of peripheral stem cell transplant and has graft versus host disease (gvhd).Was undergoing photopheresis for treatment of gvhd with a newly purchased cellex machine.The first treatment the day prior to this event was successful.During the second treatment, the machine stopped functioning and because trouble-shooting did not identify the problem, treatment had to be aborted.It was eventually determined that disposable tubing was inferior, causing machine to malfunction.Manufacturer is aware, and will improve tubing.Patient was not harmed, although one treatment was delayed.
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manufacturer response for photopheresis machine, cellex (per site reporter).
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manufacturer is aware that tubing has a problem.They are providing service representatives and trainer to assist in identifying appropriate tubing for ongoing treatments, and have agreed to improve quality of tubing manufactured for use with machine.

• Brand Name: CELLEX
• Type of Device: SYSTEM, PHOTOPHERESIS, EXTRACORPOREAL
• Manufacturer (Section D): THERAKOS, INC.; 440 route 22 east, suite 140; bridgewater NJ 08807
• MDR Report Key: 3636348
• MDR Text Key: 21731534
• Report Number: 3636348
• Device Sequence Number: 1
• Product Code: LNR
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2014

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: Invalid Data
• Device Model Number: CELLEX
• Device Lot Number: B351
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2014
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2014
• Event Location: Hospital
• Date Report to Manufacturer: 02/20/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/07/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 9 YR