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

Lot Number D303 - KIT

Device Problems Break (1069); Unintended Ejection (1234); Fluid/Blood Leak (1250); Material Fragmentation (1261); Device Damaged by Another Device (2915)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/09/2015

Event Type  malfunction  

Event Description

Customer called to report drive tube break and centrifuge bowl break during purging air phase of the single-needle mode treatment procedure, at 157 ml whole blood processed.Customer stated drive broke at the lower bearing and the centrifuge bowl shattered into pieces.Customer also noted the leak detector strip had been damaged.The customer stated the patient was alright.Css asked if anyone was injured or splashed with blood due to the drive tube break; customer stated the break was contained with in the centrifuge.Customer stated there were no alarms during prime and there were no alarms prior to the break.The customer stated they had no trouble loading the bowl and drive tube.The customer sent photos for investigation.The case was updated on 04/14/2015: the customer informed css that blood sprayed/splattered on the wall to the left side of the machine, about 6-7 feet up the wall, about 6-8 feet from the machine.The customer stated no one was splattered/splashed with the blood.Service orders, (b)(4) were generated.

Manufacturer Narrative

The system was used for treatment.A batch record review of lot d303 was performed.There were no nonconformances associated with this lot.This lot met release requirements.The uvadex lot number was not provided; therefore no batch record review could be performed.Trends were reviewed for complaint categories, drive tube leak/break and centrifuge bowl leak/break.No trends were detected.Capas have been initiated for complaint categories, drive tube leak/break and centrifuge bowl leak/break.(b)(4) completed: service technician cleaned all fluid on tube clamp at bottom of centrifuge, cleaned the fluid from leak strip and wiped with alcohol and confirmed functionality, removed all pumps and cleaned blood spillage from individual pump heads.System checkout procedure was performed with satisfactory results.All blood and fluids were cleaned.Due to new information received, in which the customer described blood exiting the centrifuge, therakos service was dispatched ((b)(4)) to check the centrifuge door.No apparent defects were found in the door seal.However, the door was replaced out of an abundance of caution.The original centrifuge door will be returned for further investigation.A supplemental report will be sent with the results of this investigation.Photos were returned for investigation.Based on the photos, it was confirmed that the drive tube and centrifuge bowl were broken.However, due to the size and resolution of the photos, no other observations could be made.Review of the device history record did not identify any related nonconformances.Therakos has initiated corrective actions to address drive tube leaks/breaks.Complaints of this nature are monitored through tracking and trending.Should a trend arise, further action is taken through the therakos continuous improvement process.(b)(4).Not returned.

Manufacturer Narrative

The manufacturer examined the returned centrifuge door and indicated that when the door to the machine was closed, it allowed a small gap to exist between the centrifuge housing and the centrifuge door seal, creating the opportunity for fluid to escape the centrifuge chamber when the drive tube began to leak.Visual inspection did not find any significant damage to the door seal.A photo analysis was conducted for this complaint.Review of the photographs confirmed a centrifuge chamber blood leak.The review of the photos indicated the following: drive tube is broken just above the lower bearing stop.Lower bearing retainer is closed and bearing is in place.Upper bearing retainer is not shown in the photos.Outer bowl cover is not locked into the platen.This could have been broken out of the platen during the failure or it could have not been locked into the platen and caused the failure.Leak detector strip is damaged.There is no witness mark on the centrifuge wall from the drive tube impacting the wall and causing the damage, an indication that the upper bearing stop did not delaminate.There is no damage to the drive tube where it enters the black clamp, an indication that the lower bearing stop did not delaminate.A review of the device history record did not identify any related nonconformances.No manufacturing defects could be determined during the analysis.This lot was produced in january 2015 and had passed all lot release testing.No specific root cause could be found for this event.This types of events are a known risk and occur at a very low level due to the high stresses of centrifugation.They are included in the risk file and the benefits of the product outweigh the risk.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYETEM
• 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: 4759942
• MDR Text Key: 21083865
• Report Number: 2523595-2015-00134
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/09/2015

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: 01/01/2017
• Device Lot Number: D303 - KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/09/2015
• Initial Date FDA Received: 05/08/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2015
• 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 Weight: 125