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

Lot Number D322 - KIT

Device Problems Occlusion Within Device (1423); Obstruction of Flow (2423)

Patient Problems Transient Ischemic Attack (2109); Patient Problem/Medical Problem (2688)

Event Date 07/25/2015

Event Type  Injury  

Manufacturer Narrative

System was used for treatment.A batch record review was performed for kit lot d322.There were no non-conformances.This lot met all 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 noncoformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for alarm #16: collect pressure, alarm #17: return pressure, clot observed or other adverse event (transient ischemic attack (tia)).However, a corrective and preventive action was initiated for alarm #16: collect pressure and alarm #17: return pressure and is now closed.Service order (b)(4) feedback is still pending at the time of this report and will be filed in a supplemental report when available.The assessment is based on information available at the time of the investigation.From uvadex perspective, there is no evidence to suggest a causal relationship between the drug and the adverse event as uvadex was not administered.This case is serious, unrelated and unexpected to uvadex.This is not reportable from a drug perspective.The adverse event, transient ischemic attack (tia), is related to the patient's underlying condition as per the patient's physician statement.The tia is not related to ecp treatment.The clot in the heart is also unrelated to ecp as per patient's physician.From a device perspective this event did not cause or contribute to a death or serious injury nor did the system cause or contribute to a death or serious injury but could have malfunctioned in a way that would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur.This case has been assessed as reportable as there was clotting in the return line & the patient required hospitalization.(b)(4).Device not returned.

Event Description

On (b)(6) 2015, (b)(6) female with history of hypercoagularity, nhl, aml, stem cell transplant, brain radiation therapy and gvhd of upper gi tract had clotting in the collect and return lines.Patient's pressure readings were high.Customer stopped the instrument to flush the access and noted clotting in the port access.Customer contacted patient physician, who agreed treatment should be aborted with no return of blood/products to the patient.Customer disconnected patient access line and was attempting to draw lab sample.She asked patient if she wanted something to drink and noted patient was not able to provide an answer.Patient had a transient ischemic attack (tia).Customer called rapid response who evaluated the patient and contacted neurology.Patient was taken to the er and admitted to the hospital for further evaluation and then discharged on (b)(6) 2015.According the patient's physician the tia was brief and resolved in minutes.Patient was discharged.Patient went back to the hospital and had other medical testing.Echocardiogram found clot in right heart and patent ovale(hole in a piece to the arterial side).Per the patient's physician, the tia is related to the patient's patent ovale.Patient is on heparin.Patient will resume ecp after port is replaced.Service order (b)(4) was dispatched.Customer did not return product for investigation.

Manufacturer Narrative

Service order ((b)(4)) feedback received: service engineer replaced collect, return and system pressure transducers, replaced rbc pump head due to sticky roller and performed system checkout procedure successfully.(b)(4).Device not returned.

• 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: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5019578
• MDR Text Key: 23688704
• Report Number: 2523595-2015-00215
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: Followup
• Report Date: 07/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 04/01/2017
• Device Lot Number: D322 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 33 YR
• Patient Weight: 92