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

Lot Number REQUEST NOT PROVIDED-KIT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 08/26/2016

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.A kit lot number was not provided; therefore, a batch record review could not be performed.The uvadex lot number was not provided.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, death.No trends were detected for this complaint category.From a device perspective, there was no known device malfunction.However, since the physician was not able to rule out the ecp treatment as a possible contributing factor in the patient's death due to the fact that an autopsy was not performed; this case is being reported out of an abundance of caution.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.Adverse event terms: death.(b)(4).

Event Description

The customer called to report that a patient who had recently started extracorporeal photopheresis (ecp) treatments, had died suddenly and unexpectedly.The customer stated that the patient's death did not occur during a treatment, and that this event was not related to a specific treatment.The patient's physician was contacted for additional information.The physician reported that they were informed by the patient's sister; that the patient collapsed while shopping.The physician stated that resuscitation was attempted, but without success.The physician reported that no autopsy was performed.The physician stated that the patient's death could be due to a cardiac cause.The physician reported that she thinks a relationship with ecp is very unlikely, but the patient was not further examined.After the call the physician sent information regarding the patient's medical history and medications, and also stated in that email; "on (b)(6) 2016, the patient underwent two straightforward photopheresis ecp treatments.On (b)(6) 2016, the patient died unexpectedly outside of the hospital following a sudden loss of consciousness for which there was mug intervention.A cardiac cause is suspected given her known cardiac disease.Another possibility could be an acute thrombotic / embolic event, secondary to the existing dialysis catheter, however given the patient's combined anticoagulant therapy this seems less likely." 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: 5989335
• MDR Text Key: 55985392
• Report Number: 2523595-2016-00217
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)151001
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Lot Number: REQUEST NOT PROVIDED-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2016
• Initial Date FDA Received: 09/29/2016
• 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): Death
• Patient Age: 63 YR
• Patient Weight: 42