MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E313 - KIT

Device Problems Fluid/Blood Leak (1250); Cut In Material (2454); Device Displays Incorrect Message (2591); Infusion or Flow Problem (2964)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/02/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e313 was reviewed.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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories tubing leak and alarm #45: red blood cell pump alarm and no trend was detected for either category.This assessment is based on information available at the time of the investigation.The product has not been received for evaluation at the time of this report, therefore investigation is still in progress.A supplemental report will be sent once investigation is complete.(b)(4).

Event Description

Customer called to report red blood cell pump alarm during treatment procedure after 524 ml of whole blood processed (wbp).Customer stated there's hardly a separation in the bowl and the red blood cells are very high.Customer checked kit and did not see any occlusions.Customer stated patient is stable.Customer pressed start and then lowered collect rate to 25 ml/min.Customer noted the interface was where it should be now.Customer stated bowl optic sensor was reading between 140-150.Customer called back for the same procedure, to report after completion of photoactivation, the return line got caught in the recirculation pump; the tubing was cut and blood leaked onto the machine.Customer stated they have aborted the procedure with no return of blood/products to the patient.Customer stated patient was stable.Customer will return product for investigation.

Manufacturer Narrative

The kit and smartcard data associated with the complaint were received for analysis.Review of the smartcard data confirmed the occurrence of reported alarms and indicated that the prime was completed successfully.Examination of the returned kit components indicated that return bag and the treatment bag had some blood and air and that there were no blood solids in the centrifuge bowl or either bag after draining.A pressure test of the return circuit and a bag kit components was performed to determine the leak.A leak was confirmed from a tear on the clear line to the photoactivation module.The cause for tear on clear line to photoactivation module could not be determined.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS; hampton NJ 08827
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5761519
• MDR Text Key: 49392019
• Report Number: 2523595-2016-00147
• 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: 06/02/2016

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: 03/01/2018
• Device Lot Number: E313 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/30/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2016
• 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 Age: 73 YR
• Patient Weight: 44