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

Lot Number D317 - KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591)

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

Event Date 11/23/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d317 was performed.There were no nonconformances associated with this lot.This 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 nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected.However, a corrective and preventive action has already been initiated for complaint category, drive tube leak/break.This assessment is based on information available at the time of the investigation.Evaluation of the photos sent by the customer is still in progress 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 leak in the centrifuge chamber at approximately 600 ml wbp during a patient treatment.Operator states she is not sure where the leak has occurred because there is a small amount of fluid in the centrifuge but there is no noticeable break or crack to the drive tube or bowl.Css confirmed that the leak detector strip is intact.The leak centrifuge alarm is what alerted the operator to the leak.Operator checked with physician to see if she should return the blood manually or abort, physician opted to abort treatment.Css instructed operator how to abort the treatment.The customer called back to share that the source of the leak was found to be a crack, described as less than a quarter of an inch, on the drive tube between the bearings.The customer sent photos for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.Review of the customer supplied photographs confirmed a crack in the drive tube.The exact location of the crack on the drive tube could not be determined.However, upper bearing stop delamination is consistent with wearing the middle of the drive tube against the wall.The analysis determined the root cause of the reported leak is, most likely, that upper bearing stop delaminated and allowed the upper drive tube enough extended length to impact the centrifuge wall.The cause of the bearing stop delamination could not be determined.Review of the device history record did not identify any related nonconformances.Corrective actions have already been implemented to address potential root causes of drive tube delamination.(b)(4).H.P.12/16/2015.Not returned.

• 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: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5286128
• MDR Text Key: 33897987
• Report Number: 2523595-2015-00306
• 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: 11/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2017
• Device Lot Number: D317 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2015
• Initial Date FDA Received: 12/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 34 YR