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

Lot Number E331-KIT

Device Problems Occlusion Within Device (1423); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e331 was conducted.There were no nonconformances associated with this lot.The lot met 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, alarm #16: collect pressure, alarm #1: air detected, and clot observed.No trends were detected for these complaint categories.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.(b)(4).

Event Description

The customer called to report multiple alarm #16: collect pressure and alarm #1: air detected alarms during the main collect phase of the procedure.The customer stated that there was no evidence of air in the tubing lines.The customer reported that when they flushed the patient's access they pulled clots out of the patient's vascular access.The customer stated that they also observed clots in both the collect and return lines.The customer reported that heparin was used as the anticoagulant and the concentration in the anticoagulant bag was 10,000 units/500ml of normal saline.The customer stated that the anticoagulant ratio was 8:1.The customer reported that the anticoagulant bag was connected to the correct fluid spike.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient was in stable condition.The customer stated that they were going to draw some labs in order to assess if there was a medical issue that caused the clotting.On 10/21/2016, the customer reported that the patient remained stable and all of the coagulation studies were normal.The customer stated that the patient did not require any medical intervention.The customer reported that the patient completed a second treatment on (b)(6) 2016 without any issues.The customer stated that they were not able to determine what had caused the clotting in the kit during the treatment on (b)(6) 2016.The customer reported that they did not test the contents of the anticoagulant bag in order to determine if the heparin was actually in the bag.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): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6115060
• MDR Text Key: 60747995
• Report Number: 2523595-2016-00246
• 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: 10/19/2016

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: 06/01/2018
• Device Lot Number: E331-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/19/2016
• Initial Date FDA Received: 11/18/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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