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

Lot Number D314 - KIT

Device Problem Device Displays Incorrect Message (2591)

Patient Problem Respiratory Failure (2484)

Event Date 05/22/2015

Event Type  malfunction  

Event Description

Customer called to ask if it was possible to return smart card in order to retrieve data.Customer stated they had to abort a treatment procedure and she inadvertently removed the smart card before writing down all of the numbers.Therakos' clinical services specialist (css) asked customer why treatment procedure was aborted.Customer stated patient went into respiratory failure during the treatment procedure.Css asked if patient complained of not feeling well prior to starting treatment procedure.This is an inpatient.Customer stated, patient seemed a little agitated but did not complain of feeling unwell.Css asked customer if there were any alarms during the procedure; customer stated there was an alarm 45 red blood cell pump alarm and buffy volume exceeded alarm during buffy coat collection.Customer opted to go to end buffy coat early due to the buffy volume exceeded alarm.Customer stated this is when the patient went into respiratory failure and the rapid response team was called to treat patient at the time of the event, as per facility.Customer aborted the procedure with no return of blood products to the patient.Several attempts were made by the therakos' css to obtain information regarding current state of the patient, but no further information has been received.Customer stated she was not been able to find further information regarding patient.Css asked if the physician who was taking care of patient was available to speak to or the nurse who was taking care of the patient, customer stated physician taking care of patient is not available and the nurse taking care of the patient is no longer working at the facility.

Manufacturer Narrative

Device was used for treatment.A batch record review was performed for lot d314.There were no non-conformances.This lot met all release requirements.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for all complaint categories and no trend was detected for other adverse event (respiratory failure) nor for alarm #19: fluid balance limit, and a downward trend was detected for complaint category alarm #45: red blood cell pump alarm.A corrective and preventive action has been initiated to investigate alarm #45: red blood cell pump alarm and is now closed.No corrective and preventive action has been initiated for other adverse event (respiratory failure) nor for alarm #19: fluid balance limit.The assessment is based on information available at the time of the investigation.Based on the information available, there is no device malfunction in this case.The adverse event (ae) is related to the fluid shift which is normal during ecp procedure.It is likely the patient's underlying condition did not allow them to tolerate the fluid shift which caused the ae to occur, since the event occurred during the ecp procedure.The smart card has not been received for analysis at the time of this report.A supplemental report will be filed if the smart card or any additional information is received.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.Meddra codes: respiratory failure - (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: 4857105
• MDR Text Key: 5806405
• Report Number: 2523595-2015-00180
• 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
• Report Date: 05/22/2015

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: 03/01/2017
• Device Lot Number: D314 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2015
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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): Required Intervention
• Patient Age: 45 YR
• Patient Weight: 53