MAUDE Adverse Event Report: THERAKOS, INC. THERAKOS CELLEX PHOTOPHERESIS SYSTEM; CELLEX ECP SYSTEM

Model Number 6661

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Loss of consciousness (2418); Confusion/ Disorientation (2553)

Event Date 01/22/2014

Event Type  Injury  

Event Description

The customer reported they found patient turning pale/ blue and about to loose consciousness while the return bag was completely empty and instrument was still returning to patient.Name of complainant: same as reporter.Customer reported at the end of the treatment, after emptying the return bag, the instrument did not stop the pump and some air got pumped in the return patient line and into the patient without any alarm being posted.Customer found patient in the condition stated above.Doctors intervened and gave o2 to patient.After a while, patient felt better and was not admitted to the hospital.Patient is still feeling fine today after 5 days, no report of permanent harm for the patient after the day of incident.Customer kept using this instrument in the following days and paid attention towards the end of the treatments.This issue has not reoccurred.In an email, the customer stated to therakos field technical service that she returned from her break, taking over from another nurse and the matron, to find the patient cyanosed, disorientated and losing consciousness.Customer reported that the patient had been taking his salbutamol inhaler.She stated that she noticed that the bags and return line were empty.Customer stated that stop was pressed and the lines clamped.The patient was placed in the trendelenburg position and o2 was given.The patient's bp was unchanged and o2 sats returned to normal with o2 therapy.Customer stated that the patient appears to not have had any lasting effects.The instrument has continued to be in use with no further events reported.Service order # (b)(4) was dispatched to inspect the instrument.No product was returned by the customer for investigation.

Manufacturer Narrative

A review of lot file b135 was performed.There were no nonconformances or alarms associated with this event type reported for this lot.This lot met all release requirements.A review of complaints received for lot b135 was performed.There were no other reports of this type of occurrence reported to date for this lot.Service order feedback: field engineer checked air detector unit and collect/treatment load cells.The air detector was tested 3 times with and without fluid and it performed as expected.The load cells read 175 and 180 grams with a 200g weight.The engineer recalibrated the load cells.This small weight discrepancy would have little to no effect.The instrument has been returned to its intended use.This assessment is based on the information available at the time of the investigation.Customer reported the incident 5 days after the occurrence.No product/smart card was made available by the customer for investigation.Therefore, we cannot determine if the air detector alarmed.It is highly unlikely that air would get to the patient without an alarm sounding or the attending operator not observing air in the kit, bags, filter or lines.The instrument continued to be used after the event and prior to servicing without incident.The service order feedback demonstrate that the device was functioning as designed.Thus, it is not likely that the event was triggered by the product.No specific cause of the patient even can be determined based solely on the information provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX ECP SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 e suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3628848
• MDR Text Key: 4204403
• Report Number: 2523595-2014-00053
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P680003
• 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: 01/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2015
• Device Model Number: 6661
• Device Lot Number: B135-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 02/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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
• Treatment: CETRIZINE; MYCOPHENOLATE MOFETIL; ZOPICLONE; SALMETEROL/FLUTICASONE; ACICLOVIR; CONTRIMOXAZOLE; BUDESONIDE; FERROUS FUMARATE; PENICILLIN V; CICLOSPORIN; IVIG; SALBUTAMOL; CHOLECALCIFEROL; AMILORIDE; DOMPERIDONE; LANSOPRAZOLE; ONDANSETRON; PREDNISONE; FLUCONAZOLE
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR
• Patient Weight: 76