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

Lot Number REQUESTED, NOT PROVIDED

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Thrombosis (2100)

Event Date 03/16/2015

Event Type  Injury  

Event Description

Customer contacted clinical support via e-mail.They have a patient who they treat fortnightly, who two weeks ago got thrombosis in the right arm due to a peripheral vein catheter that was left in the arm.He was given injections of fragmin 15000ex1, he had the first injection the evening before the next last treatment cycle, two weeks ago.They made a single needle treatment with a/c ratio 1:16 (they are using acd-a).After the treatments they saw clots in the bowl.The following day they changed the a/c ratio to 1:12 but could still observe clots in the bowl after finished treatments.Yesterday, 2 weeks later - during which he has had fragmin - they used the a/c ratio 1:10 and there were still clots afterwards.The "bleeding status" looks normal.They are now wondering how to proceed with this patient to avoid clots.Css has planned a phone call with the customer tomorrow (b)(6) to discuss practical aspects of the treatment and will also request more information regarding the patient.It appears from the report that the thrombosis was not due to ecp, since it happened before the next last treatment cycle.Css will ask the customer about this.The question is transmitted to medical affairs as well.Update (b)(4) 2015: discussed with the nurses.All treatments have been finished without problems and the patient is stable.The nurses asked if there was a risk of clots reaching the patient, css explained that the transfusion filter on the return line will block clots.Treatments were previously made in double needle mode.Since the thrombosis, they only use single needle with return bag threshold value at 100 ml.The collect rate is 50 ml/min and there have never been any problems with pressure alarms.The patient's platelet count at the last treatment cycle was 152*10^9/l.The hematocrit is normally around 36-37%.The first fragmin injection was made before the next last ecp cycle started.Css asked if they want to discuss with medical affairs, nurses suggested that their physician may be interested.Css contacted physician, currently on vacation.Update (b)(4) 2015: the nurses confirmed that the thrombosis occured before ecp.The patient is stable and the treatments are continuing.The physician has not requested to talk to medical affairs.

Manufacturer Narrative

The kit lot number was not reported; therefore, no batch record review was performed.A review of complaint categories shows no trends for thrombosis or clot observed.No capa has been initiated for these complaint categories.Based on the internal medical assessment, adult male patient with gvhd developed thrombosis in the right arm due to a peripheral vein catheter that was left in the arm.Patient was treated with injections of fragmin 15000ex1.The injections started before next last ecp treatment cycle.The patient's platelet count at the last treatment cycle was 152*10^9/l.The hematocrit is normally around 36-37%.The nurses confirmed that the thrombosis occured before ecp.The patient is stable and the treatments are continuing.Patient was on acda anticoagulant which ratio was adjusted from 16:1 to 10:1 to prevent clotting during procedure.Uvadex was administered but this case is not related to the drug because uvadex does not cause clotting.Patient's underlying condition of having a peripheral veinous catheter is the probably cause of the thrombosis.This is not a medical device malfunction.This case is serious as medical intervention was necessary, and probably unrelated to therapy.Clots were observed during treatment.This assessment is based on information available at the time of investigation.No product was returned for investigation; therefore it could not be determined if the product met specifications based solely on information provided by the customer.Complaints are monitored through tracking and trending.Should a trend arise, further action will be taken.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS INC.; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 4718042
• MDR Text Key: 20119009
• Report Number: 2523595-2015-00111
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2015

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, NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2015
• Initial Date FDA Received: 04/22/2015
• 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