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

Lot Number C364

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Dyspnea (1816); Hemoptysis (1887); Pulmonary Edema (2020); Tachycardia (2095); Test Result (2695)

Event Date 03/17/2015

Event Type  Injury  

Event Description

Customer called to report an air detected alarm at the end of reinfuse, customer stated that the return line was full of air.Customer stated that the patient was coughing, spitting up red sputum, and had an increased pulse rate.Customer explained that the patient was taken to the emergency room via ambulance.Customer stated that she does not have any information on the patient's condition but will know further information tonight or tomorrow morning.The kit and smart card were returned for investigation.Service order, (b)(4), was dispatched.Case was updated (b)(6) 2015: patient admitted to icu, on ventilator, diagnosis of pulmonary edema.Case was updated on (b)(6) 2015: the customer confirmed that pulmonary embolism was ruled out via chest xray and heart ultrasound.

Manufacturer Narrative

A batch record review of lot c364 was performed; there were no nonconformances related to this complaint.This lot met release requirements.Trends were reviewed for all complaint categories involved in this complaint.An upward trend was detected for alarm #1: air detected; no trends were detected for complaint categories, coughing up blood, heart rate increased, or pulmonary edema.A corrective and preventive action was initiated for complaint category, alarm #1 and is now closed.No corrective and preventive actions were initiated for complaint categories, coughing up blood, heart rate increased, or pulmonary edema.Service order (b)(4) feedback: service technician powered up the system with no alarms.Repowered system into local diagnostics.Checked air detector, valves, load cells; all were performing as expected.Technician tightened loose treatment bag hanger, and removed and inspected all pump heads.System checkout procedure was performed; all values were in specification.No issues were found.A water treatment was performed using simulated air in line tests.System alarms occurred as expected.No issues were found during the water treatment.System was returned to service.Based on internal medical assessment, (b)(6) y/o male with gvhd and post transplant mds increased heart rate and coughing up blood during treatment.Patient's return line was full of air.Patient was sent to hospital and was diagnosed with pulmonary edema via chest x-ray.Patient is in the icu on the ventilator.Because the patient is post transplant for mds, the underlying condition is the probable cause.However, since the ae happened during treatment, ecp can not be ruled out.This case is serious and possibly related to ecp.This assessment is based on information available at the time of the investigation.Evaluation of the returned kit is still in process.A supplemental report will be filed when this assessment is complete.(b)(4).

Manufacturer Narrative

The case was updated on april 23, 2015.The clinical services specialist contacted the customer to obtain patient status; the customer stated the patient is doing well and has resumed ecp treatments as an in-patient.Customer stated the patient will be discharged at the end of this week and will continue receiving out-patient ecp post discharge.Customer stated that the treatment may have "pushed the patient to a fluid overload state." customer stated they were running the cellex treatments at a 35-40ml/min collect rate and a 40ml/min return rate; they are now treating the patient with collect and return rates at 30ml/min and the patient is tolerating the treatment without issue.Customer stated the patient was diagnosed with congestive heart failure and respiratory edema.(b)(4).

Manufacturer Narrative

The smart card and kit components were returned for analysis.Review of the smartcard data indicated several return pressure alarms and an air detected alarm were seen.The returned pto and the routing of the lines in the pto were visually examined and no defects were seen.The pto and the lines (ac, collect, and return) around the pto and circuit were pressure tested for leaks.No leaks were found in the ac line or the return circuit that would have caused the air detected alarms.(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: 4666733
• MDR Text Key: 5621812
• Report Number: 2523595-2015-00093
• Device Sequence Number: 1
• Product Code: LNR
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 03/17/2015

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 Expiration Date: 12/01/2016
• Device Lot Number: C364
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/17/2015
• Initial Date FDA Received: 04/08/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/13/2015; 05/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2014
• 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: 45 YR
• Patient Weight: 88