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

Lot Number D372 - KIT

Device Problems Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot d372 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 all complaint categories and no trend was detected for drive tube leak/break or alarm #7: blood leak? (centrifuge chamber).Service order feedback is still pending at the time of this report.Service order feedback information to be included in final report.This assessment is based on the information available at the time of the investigation.Analysis of the submitted photos and the smart card data is still in process at the time of this report.A supplemental report will be created once the investigation is complete.(b)(4).Device not returned.

Event Description

Customer called to report centrifuge blood leak alarm during buffy coat collection.Prior to the alarm, customer heard a sound like something came loose.Customer clamped the patient lines and opened the centrifuge.Customer noted blood throughout the centrifuge; tubing intact.Customer states it appears the white upper bearing collar was loose.Treatment aborted.Patient provider called and ordered post cbc.Patient hematocrit dropped 3% and transfusion was ordered.Patient reported to have vitals stable.Service was dispatched.The customer will return the smart card and photos for investigation.

Manufacturer Narrative

Service order (b)(4) completed: service engineer completed system checkout successfully and performed water treatment.The kit, photos and smartcard data were submitted for analysis.Review of the data indicated that the prime was completed and the treatment proceeded until the buffy coat collection.A blood leak alarm, a system pressure alarm and a return pressure warning were noted after processing of 1461 ml of whole blood and the treatment was ended.Review of the photos and the returned kit indicated that the upper bearing stop on the drive tube had delaminated.Analysis indicated that the upper bearing stop delaminated, causing the drive tube leak.The root cause of the reported leak is likely that an upper bearing stop delaminated and allowed the upper drive tube to twist and break.The upper drive tube twist is the site of the blood leak.Therakos has already initiated corrective and preventive actions to investigate drive tube leaks/breaks.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; hampton NJ 08827
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 baily ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5526242
• MDR Text Key: 41653731
• Report Number: 2523595-2016-00069
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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: 03/04/2016

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: 12/01/2017
• Device Lot Number: D372 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/04/2016
• Initial Date FDA Received: 03/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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: 12 YR
• Patient Weight: 41