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

Lot Number REQUESTED BUT NOT PROVIDED-KIT

Device Problem Break (1069)

Patient Problem Swelling (2091)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

The system was used for treatment.A kit lot number was not provided; therefore, a batch record review could not be conducted.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 category, swelling.No trend was detected for this complaint category.The patient's swelling occurred prior to the administration of uvadex and the treatment was aborted immediately after the swelling was seen.Therefore, this is not reportable from a drug perspective.From a device perspective, there was no device malfunction.However, since the device contributed to the swelling of the broken catheter and a medical procedure was required to remove the catheter, this case will be reported as an mdr.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.Adverse event term: swelling.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report that she was "about halfway through a procedure" when she noticed swelling by the patient's left central venous catheter (cvc) which was used to run the procedure.The customer stated that the procedure was aborted at this time with no blood/products returned to the patient.On may 24, 2016, the customer reported that after the procedure, it was determined that the patient's central line was broken.The customer stated that the patient's central line was then removed post treatment.The customer reported that the patient did not have a history of swelling at this cvc site.The customer stated that she was only in charge of doing the extracorporeal photopheresis (ecp) treatment and did not follow the patient after the procedure.Thus the customer reported that she did not know when the patient was discharged to go home or if any additional hospitalization was required related to the event.The customer stated that the patient was on an every 6 week schedule, so the patient had not had another ecp treatment since the event.The customer stated that she had nothing further to report.The kit was not returned for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5698662
• MDR Text Key: 46569984
• Report Number: 2523595-2016-00137
• 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: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Nurse
• Device Lot Number: REQUESTED BUT NOT PROVIDED-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/13/2016
• Initial Date FDA Received: 06/03/2016
• 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
• Patient Outcome(s): Required Intervention