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

Lot Number NOT APPLICABLE-KIT

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

Patient Problems Pulmonary Embolism (1498); Death (1802); Hemorrhage/Bleeding (1888); Pain (1994)

Event Date 08/05/2016

Event Type  Death  

Manufacturer Narrative

The system was used for treatment.The kit lot number was not provided; therefore, a batch record review could not be performed.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, pulmonary embolism, intra-abdominal hemorrhage, and pain.No trends were detected for these complaint categories.From a device perspective, although the customer stated that it was highly unlikely that the patient's adverse events were related to the ecp treatment; it cannot be ruled out as a contributory cause of the event.Thus out of an abundance of caution this case will be reported as a 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.Adverse event terms: pulmonary embolism, hemorrhage, and pain.(b)(4).Device not returned to manufacturer.

Event Description

On august 16, 2016, the customer called to report that a patient had to be admitted to the hospital on (b)(6) 2016, due to a lung embolism and psoas bleeding.The customer stated that the patient's last extracorporeal photopheresis (ecp) procedure was on (b)(6) 2016 and then two days later the patient was admitted to the hospital.The customer reported that during the patient's last ecp procedure, the instrument slowed during the buffy coat collection.Due to this and a high hematocrit level; the patient received 64 minutes of uva exposure during the photoactivation phase of the procedure.The customer stated that the ecp procedure on (b)(6) 2016, was the patient's eighth session.The customer reported that they did a full blood panel and there was nothing out of the ordinary.The customer stated the patient's skin was paler but his mouth and mucosa were subjectively better.The customer reported that the patient was still in pain and that his "skin felt very stiff." on august 22, 2016, the customer stated that the patient was admitted to the hospital two days after his second ecp treatment for that session.The customer reported that the patient was feeling ill before he came to us.The customer stated that the patient's ecp treatments could not be ruled out as a possible cause for the patient's adverse events; but since they did do a full blood panel and had treated the patient with citrate, they felt it was highly unlikely.The customer reported that the patient was feeling better after his last ecp treatment.The customer stated that there was no medical intervention after the patient's last ecp treatment other than the bloodwork that they performed.On september 1, 2016, the customer reported that the patient was hospitalized at another hospital so they did not have any additional information on the patient's hospitalization.The customer stated that the only thing that they knew was that the patient was still hospitalized and in pain.The customer reported that due to the patient being admitted to a different hospital, no additional ecp treatments have been possible.On september 13, 2016, the customer stated that the patient had been discharged from the hospital on (b)(6) 2016.The customer reported that the patient had been transferred to a rehabilitation facility and was still not fit to be considered for more ecp treatments.The customer stated that as far as they could tell from the patient's discharge summary, the patient's reason for being admitted to the hospital was not directly related to his ecp treatments.The kit was not returned for investigation.

Manufacturer Narrative

The information contained in this supplemental report does not affect the method, result, or conclusion codes that were reported in the initial medwatch for this complaint.Adverse event term: death.(b)(4).

Event Description

The customer reported on october 26, 2016 that the patient had died.The customer stated that they did not know the patient's cause of death.The customer reported that the patient had not received any additional extracorporeal photopheresis treatments since his hospitalization on (b)(6) 2016.The customer stated that the patient's last extracorporeal photopheresis treatment was on (b)(6) 2016.On october 28, 2016, the customer reported that the patient had died from septicemia on (b)(6) 2016 at the local hospital.The customer stated that they didn't think the patient's cause of death was related to his extracorporeal photopheresis treatment.

• 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: 5954226
• MDR Text Key: 54881214
• Report Number: 2523595-2016-00197
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: (01)10705030100009(11)150922
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Device Lot Number: NOT APPLICABLE-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/16/2016
• Initial Date FDA Received: 09/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• 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; Hospitalization
• Patient Weight: 65