MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLERX PHOTPOPHERESIS SYSTEM; CELLEX

Lot Number D333 - KIT

Device Problems Break (1069); Leak/Splash (1354); Difficult to Remove (1528); Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 09/29/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A review of kit lot d333 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided, since 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 alarm #7: blood leak? (centrifuge bowl) and centrifuge bowl leak/break and no trends were detected.However, a corrective and preventive action was initiated for centrifuge bowl leak/break and is now closed.Feedback from service order, srv-2577, and the analysis of the returned product is still pending at the time of this report.A supplemental report will be filed when this analysis is complete.(b)(4).

Event Description

Customer called to report a blood leak at the completion of purge air.Customer heard a "pop" and then a loud bang.Alarm #7: blood leak? (centrifuge chamber) occurred.The treatment was aborted.Customer stated, the drive tube and bowl are in place; all tubing looks appropriate.Customer suspected the leak was coming from the base of the bowl.Customer was unable to remove the bowl and stated it appeared that one of the bowl tab latches was broken.Clinical services specialist informed the customer that service will remove the bowl if they are unable to do so.Service order, srv-002577, was dispatched.The customer returned photos and parts of the kit for investigation.

Manufacturer Narrative

(b)(4), was completed.Service technician replaced bowl holder and cleaned up the instrument.System checkout and water treatment were completed with satisfactory results.The centrifuge bowl and drive tube were returned for analysis.Testing of the returned components indicated a leak from a location on the bowl near one of the locating tabs and its slot on the bowl holder.Review of the photos showed that the base of the bowl was cracked in several places around its circumference.Photos also showed that the crack is above and through the weld area and continues below the weld on the cover of the bowl.Testing of the bowl holder and bowl fit did not indicate any fit issues.The cause of the leak is the bowl break; however, the root cause of the bowl break could not be determined.All welding parameters were within the qualified ranges and a material trace of the two components found no nonconformances.No trends were detected for centrifuge bowl leak/break.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(b)(4).

• Brand Name: THERAKOS CELLERX PHOTPOPHERESIS 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: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5163381
• MDR Text Key: 29044451
• Report Number: 2523595-2015-00268
• 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: 09/29/2015

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: 06/01/2017
• Device Lot Number: D333 - KIT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2015
• Initial Date FDA Received: 10/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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 Age: 33 YR
• Patient Weight: 74