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

Lot Number UNKOWN

Device Problem Leak/Splash (1354)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 12/18/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.No kit lot number was provided; therefore, batch record review could not be conducted.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No noncoformances related to the complaint were noted.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trend was detected for this complaint category.A corrective and preventive action was already initiated for complaint category centrifuge bowl leak/break.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

Event Description

Email received on 21-dec-2015, identified as case# (b)(4), stating that a physician reported an apparent centrifuge bowl leak/break.However, the information could not be verified at that time.On 21-dec-2015: clinical service representative attempted to contact the reporter to gather additional information.No contact was made with the reporter.On 22-dec-2015: the reporter called clinical services back and explained that since this was a double blinded survey there was no further information available for the customer, patient or event.And, no additional information would be able to be obtained.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5359915
• MDR Text Key: 36245518
• Report Number: 2523595-2016-00013
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2015

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: Other
• Device Lot Number: UNKOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/21/2015
• Initial Date FDA Received: 01/12/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1