MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E323 - KIT

Device Problems Leak/Splash (1354); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/06/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e323 was reviewed.There were no non-conformances related to the complaint.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 pump tubing organizer (pto) leak, alarm #1: air detected and alarm #9: blood pump error and no trend was detected for either of these categories.Service order (b)(4) completed: service engineer checked for faulty pump.Pump checks ok and pump head is also ok.Service engineer reset error for pump and performed systems check out procedure successfully.The kit, photos and smartcard data associated with the complaint were received for analysis.Review of the smartcard data indicated that the prime was completed successfully and several blood pump error warnings against the collect pump motor and an air detected warning for air in the ac line were seen.After processing of 199 ml of whole blood an air detected warning was recorded at every event to the last event on the card.The returned kit was examined and review of the provided photos confirmed a cut/tear on the plasma line inside the pto.A pressure test confirmed a leak at the site of the cut/tear.A closer view of the cut/tear indicated the cut/tear was not clean; it looked like it had been made by something with a blunt edge, leaving some upset tubing material on one side of the cut/tear.Testing confirmed a leak in the plasma line, as reported, but examination of the site of the leak did not indicate that there was a manufacturing issue with the tubing.Per additional information received on 2-august, 2016, via user facility medwatch ref# mw5063524, the likely cause of the cut/tear was the use of a screwdriver by the nurse to release the recirculation occlude valve.(b)(4).

Event Description

Customer called to report a blood pump error at 199 ml of whole blood processed (wbp).Customer reported that the only pump active at that point was the recirculation pump.No debris was noticed in the pump and the pump tubing segments seemed to be normal length.Customer cleared the alarm and then immediately received air detected alarms that she was unable to clear.Manual blood return with the power off was performed per the operator's manual.When the customer was lifting the return bag to drain the contents into the treatment bag, a blood leak was noticed on the pump deck.Customer did not return this blood to the patient.Patient was stable.Customer refused to answer patient related questions.Service evaluation was initiated.Customer provided photos and returned the kit for evaluation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5848240
• MDR Text Key: 52406346
• Report Number: 2523595-2016-00169
• 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
• Report Date: 07/06/2016

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: 05/01/2018
• Device Lot Number: E323 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2016
• Initial Date FDA Received: 08/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2016
• 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