MAUDE Adverse Event Report: THERAKOS, INC CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); No Audible Alarm (1019); Bent (1059); Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Material Fragmentation (1261); Device Displays Incorrect Message (2591); Physical Property Issue (3008)

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

Event Date 11/01/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A device history review was performed.The instrument has been located at the customer's site since 07/24/2009.The instrument was last serviced on 08/03/2016 and the system checkout procedure was successfully completed.The instrument had passed all tests, met all specifications, and was operational.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber) and centrifuge bowl leak/break.No trends were detected for these complaint categories.However an issue review was opened for complaint category, centrifuge bowl leak/break in order to investigate further.This assessment is based on information available at the time of the investigation.At the time of this report, the manufacturer was still waiting on the instrument return.A supplemental report will be filed when the instrument has been received and the analysis of the instrument is complete.(b)(4).Device not yet returned to manufacturer.

Event Description

The customer called to report a centrifuge bowl leak/break during the purging air phase of a treatment.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient did not require any medical intervention, and they planned to start a new treatment for this patient on a different instrument.The customer stated that when the centrifuge bowl leak/break occurred, "there was not a stop button".The customer reported that they did not remember hearing or getting an alarm.The customer stated that they turned off the power to the instrument after the centrifuge bowl leak/break, and when they turned the power back on, they received an alarm #7: blood leak (centrifuge alarm).The customer reported that there was at least a three inch section of the fluid leak detector strip that was damaged.The customer stated that the centrifuge bowl was shattered and no part of the bowl remained attached to the bowl holder.The customer reported that the lower bearing of the drive tube was still installed, but the lower bearing clip was bent.The customer stated that the upper bearing of the drive tube was no longer attached, but the customer did not note if the upper bearing clip was damaged.Service was requested.On november 2, 2016, the customer reported that plastic pieces from the shattered centrifuge bowl, as large as 1x 1 inch, escaped from the centrifuge door.The customer stated that one piece landed on the floor.The customer reported that the bottom drive tube bearing clip appeared to be slightly bent and the fluid leak detector strip was shredded.The customer stated that the blood leaked onto the instrument's pump deck.The customer reported that two operators confirmed the kit's loading prior to priming the kit, and both of these operators had attended recent training.On november 8, 2016, the decision was made to exchange this instrument as a result this instrument will not be serviced.This instrument will be returned for investigation.The instrument was returned for investigation.The kit based reported will be submitted under medwatch 2523595-2016-00268.

Manufacturer Narrative

The cellex instrument (s/n (b)(4)) was returned for investigation.A visual inspection of the interior of the centrifuge chamber found damage to the walls as well as damage to the interior side of the centrifuge chamber door window.The visual inspection also confirmed that the centrifuge leak detector strip was broken.Multiple cracks in the side panels of the instrument were also seen, which was indicative of the instrument's heavy use.The visual inspection of the instrument also determined that the centrifuge door's gasket was not installed.The gasket was found packed into the centrifuge chamber and was determined to have been undamaged.The gasket had been removed in order to properly clean the instrument prior to shipping the instrument to the manufacturer's site.The instrument's centrifuge chamber door was physically inspected and a noticeable amount of free play was observed when the locked centrifuge chamber door was pulled.Upon further inspection the flats of the pin on the left door hinge to which the upper part of the gas strut is attached was found to be damaged.This indicated that the wrong tool was likely used to remove or install the pin when the door assembly was replaced.In addition, the middle bolt for the left hinge plate was found to be missing from the instrument.Evidence suggests that either one or both sides of the centrifuge door lock was not properly aligned.The amount of free play when the centrifuge chamber door was locked was measured at 1/2" between the door at rest and when the locked door handle was pulled.A review of the service records for this instrument found that the instrument's centrifuge door had been replaced twice in its lifetime the centrifuge chamber door's gasket was reinstalled on the centrifuge chamber door.After several attempts in adjusting the door's interlock assembly, the free play in the locked centrifuge chamber door was reduced to 3/16".The visual examination and physical testing of the instrument did not find any indication that there was an issue with the instrument as manufactured.The device history record review indicated that the instrument was manufactured in july 2009 and had over seven years of service in the field.The instrument's internal software indicated that the instrument had undergone 6083 hours of use.A review of the service records for this instrument indicated that the door assembly of this instrument was replaced twice in 2016 along with the door's interlock assembly.The visual inspection of this instrument concluded that both the interior of the centrifuge door and the centrifuge chamber itself had extensive damage.The investigation determined that the centrifuge chamber door's interlock assembly was not in proper adjustment which caused the centrifuge door to have some movement in the locked position.The results of this investigation have been provided to the instrument's service provider.This investigation is now complete.(b)(4).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6140335
• MDR Text Key: 61607159
• Report Number: 2523595-2016-00269
• 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,Followup
• Report Date: 12/01/2016

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 12/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/17/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1