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

Lot Number D336-KIT

Device Problems No Audible Alarm (1019); Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d336 was conducted.There were no nonconformances associated with this lot.The 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 category, drive tube leak/break.No trends were detected for this complaint category.However, a capa has been initiated for the investigation of the cause of drive tube leak/break associated complaints.Service order report, #4108984, feedback: the service technician cleaned the instrument and replaced the door seal, the two drive tube retainer clips, and the ir lens cover.The service technician then reinstalled all of the instrument's panels and successfuly completed the system checkout procedure.This assessment is based on information available at the time of the investigation.The analysis of the returned photos is still in progress.A supplemental report will be filed when the analysis of the photos is complete.(b)(4).S.K.11/15/2016.Device not returned to manufacturer.

Event Description

The customer called to report that a drive tube leak/break occurred at approximately 500ml of whole blood processed.The customer stated that as soon as they heard the noise of the drive tube leak/break, they immediately shut off the power to the instrument.The customer reported that they did not hear any alarm.The customer stated that they disconnected the patient from the instrument, and aborted the treatment with no blood/products returned to the patient.The cusomer reported that the patient was in stable condition.The customer stated that they did not get any alarm when the drive tube leak/break occurred or when they turned the instrument back on.The customer reported that the centrifuge bowl remained intact and was still attached to the centrifuge bowl holder.The customer stated that the centrifuge bowl did not break.The customer reported that the drive tube bearings also remained intact on the drive tube, and that the drive tube bearings remained attached to the drive tube bearing retainer clips on the arm of the centrifuge frame.The customer stated that there appeared to be a vertical slit in the middle of the drive tube, and the customer believed that this slit was the site of the leak.The customer reported that they removed the kit from the instrument and then discarded the kit.The customer stated that the instrument would be placed out of service until it could be assessed and repaired.Service was requested photos were submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the drive tube leak/break.The drive tube in the photos appeared to be twisted.The most likely cause for the drive tube leak/break was bearing stop delamination which caused the drive tube to elongate and wear against the centrifuge chamber wall.The root cause for the leak could not be determined.A review of the device history record did not identify any related nonconformances.Corrective actions have already been initiated to address the potential root causes of drive tube delamination.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• 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 ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6107605
• MDR Text Key: 60561578
• Report Number: 2523595-2016-00261
• 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: 10/18/2016

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: 06/01/2017
• Device Lot Number: D336-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/16/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/09/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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