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

Lot Number D364-KIT

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/23/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review for kit lot d364 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 trend was detected for this complaint category.However, a corrective and preventive action has already been initiated for the investigation of drive tube leak/break.Service order report, (b)(4), is still pending.A supplemental report will be filed when the service order report is complete.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.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).Device not returned to manufacturer.

Event Description

The customer called to report a drive tube leak at the start of the purging air phase.The treatment was aborted with no blood returned to the patient.The customer stated that when the drive tube was loaded it did not seem to have been loaded correctly, so she had another operator check it as well.The customer was able to complete prime successfully without any alarms.The customer reported that there were no alarms prior to the drive tube leak.The customer stated that the patient was stable.The customer requested service.The customer elected not to return the kit for investigation as the kit has already been discarded.

Manufacturer Narrative

(b)(4).The service technician cleaned the instrument and successfully completed the system checkout procedure.The information contained in this service order report does not affect the codes that were reported in the initial medwatch for this complaint.(b)(4).

• 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: 5513554
• MDR Text Key: 41308177
• Report Number: 2523595-2016-00073
• 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: 02/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 10/01/2017
• Device Lot Number: D364-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2015
• 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: 50 YR
• Patient Weight: 79