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

Lot Number D349-KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d349 was conducted.There were no nonconformances associated with this lot.The lot met 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 complaint categories, centrifuge bowl leak/break and alarm #45: red blood cell pump alarm.No trends were detected for these complaint categories.A corrective and preventive action was initiated for complaint category, centrifuge bowl leak/break, and is now closed.Service order, (b)(4), feedback: service was dispatched and the service technician cleaned all fluid from the interior and exterior of both the unit and centrifuge chamber.The service technician removed all the pumps and cleaned them as well as their housings.The service technician then adjusted the pumps.He replaced the o ring, leak sensor, and pressure sensor.He then calibrated the sensors and successfully performed the system checkout procedure.This assessment is based on information available at the time of the investigation.The analysis of the photos is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer called to report a blood leak from the centrifuge bowl during a patient treatment.The customer explained that several alarm #45: red blood cell pump alarms occurred during the treatment.The customer stated that they purged the bowl along with reducing the collect flow rate.However, another alarm #45: red blood cell pump alarm occurred, so they removed the centrifuge bowl from its holder and "shook the bowl upside down." the customer stated that they did verify that the bowl was properly re-installed before resuming the patient treatment.The customer stated that a blood leak occurred at approximately 600ml of whole blood processed.The treatment was aborted and the blood was not returned to the patient.The patient was reported to be in stable condition.Service order, (b)(4), was generated to check this instrument.Photos were submitted for investigation.

Manufacturer Narrative

Photos were returned for analysis.A review of the photos indicated that the break was both above and below the joint of the bowl and the cover.A review of the cover to bowl welding parameters for the lot were found to be within the qualified ranges during manufacturing.A material trace for both the bowl and cover found no nonconformances.Based on the evaluation the root cause of the bowl break could not be determined.A review of the device history record found no related nonconformances.The lot had passed all lot release testing.(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: megan vernak ; 53 frontage road; suite 300; hampton, NJ 08827
• MDR Report Key: 5312083
• MDR Text Key: 34668262
• Report Number: 2523595-2015-00325
• 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 faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 11/25/2015

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: Nurse
• Device Expiration Date: 08/01/2017
• Device Lot Number: D349-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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