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

Lot Number C358/70

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

Patient Problem Stroke/CVA (1770)

Event Date 02/09/2015

Event Type  Injury  

Event Description

The patient that came in for her day 2 ecp treatment and had a limp on (b)(6) 2015.Upon further investigation the patient explained that the whole right side of her body was numb for about 1.5 days.The customer escorted the patient to the er, the er did a ptt test that resulted in critical, a ct scan that showed no active bleeds, and an mri that showed an acute ischemic stroke (left thalamus 8mm).The customer stated that ecp therapy is currently on hold for this patient until the complete work up is complete.Currently the patient is admitted and is stable.The last ecp treatment for this patient was on (b)(6) 2015, patient hematocrit was 33%, platelet count 428,000 using 10,000 units of heparin in a 500ml bag of normal saline set at a 10:1 a/c ratio.On (b)(6) 2015 the patient had a blood pressure of 161/68, hematocrit of 32.6%, platelet count of 311,000 before being escorted to the er.Customer has declined to return the kit for investigation.On (b)(6) 2015, the customer stated the ptt result was 124, that was drawn through the patients port that was packed with 500 units of heparin.Customer stated that no new labs had been drawn since (b)(6) 2015 when the patient was admitted to the hospital.The labs drawn upon hospital admission were the following; h/h: was 10.8/32.6 and the patient's platelet count was 311,000.The customer stated the patient was discharged on (b)(6) 2015 and the only new medication prescribed was plavix, no physical therapy needed, the patient was encouraged to go on walks, eat heart healthy, and follow up with a neurologist.The patient's oncologist, (b)(6), will see the patient before starting up photopheresis again.On (b)(6) 2015, css updated the case: the treating physician does not believe there is a correlation between the patient's stroke and the administration of uvadex.Patient received ecp on (b)(6) and (b)(6).Patient reports her numbness is still present but half of what it was originally, and patient is reportedly walking better.She is to remain on her new medication of plavix until it is discontinued and is still scheduled to see a neurologist in the near future.

Manufacturer Narrative

A review of c358 was performed and there were no nonconformances related to this complaint.This lot met release requirements.Trends were reviewed for complaint category, other adverse event (acute ischemic stroke) and no trends were detected.There was no capa initiated.This assessment is based on information available at the time of this report.No product was returned for evaluation; therefore, it could not be determined if this specific product met specifications.Based on internal medical assessment, (b)(6) female, complaining of limp, then diagnosed with acute ischemic stroke.Patient had first treatment on (b)(6), and woke up the morning of (b)(6) with her reported symptoms.Patient has history of hypertension and hypercholesterolemia, no prior known history of cva, cardiovascular disease, or transient ischemic attacks.Medication list: asa (aspirin), synthroid, mvi, fluconazole, hydrochlorothiazide, lisinopril, folic acid, prevastatin, lexapro, valcyclovir, tacrolimus and protonix.History of mud (matched unrelated donor) stem cell transplant in 2012.There is a negative rechallenge, an unequivocal statement about no relation to uvadex.Therefore not related to uvadex.A temporal relationship to ecp cannot be ruled out.Kit unique identifier (udi) #: (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 baily ave.; buffalo NY 14211
• Manufacturer Contact: 10 north high street, suite 300; west chester, PA 19380
• MDR Report Key: 4584648
• MDR Text Key: 5481457
• Report Number: 2523595-2015-00059
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/12/2015

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: Health Professional
• Device Expiration Date: 11/01/2016
• Device Lot Number: C358/70
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/12/2015
• Initial Date FDA Received: 03/09/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 64