MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E337 - KIT

Device Problems Complete Blockage (1094); Human Factors Issue (2948)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/29/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e337 was reviewed.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories clot observed and bags/lines swapped and no trend was detected for these categories.This assessment is based on information available at the time of the investigation.After multiple attempts from therakos to obtain further information regarding this event, it is unknown as to where the clot was specifically located, hence out of the abundance of caution, this event is being reported.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.However, per complaint's description, the most likely cause for the clot observed in the kit was the error when spiking the anticoagulant and saline bags.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.(b)(4).Device not returned.

Event Description

Customer called to report clotting found in the kit during a single needle mode procedure.Customer stated saline and anticoagulant bags were swapped.Customer stated they did not note the bags were stopped till elutriation phase of the treatment procedure.Customer stated they aborted the procedure with no return of blood/products to the patient.Patient reported to be stable.Customer did not return product for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6064626
• MDR Text Key: 59047833
• Report Number: 2523595-2016-00237
• Device Sequence Number: 1
• Product Code: LNR
• 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: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/29/2016

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: Nurse
• Device Expiration Date: 07/01/2018
• Device Lot Number: E337 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2016
• Initial Date FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• 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