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

Lot Number E315-KIT

Device Problems Air Leak (1008); Fluid/Blood Leak (1250); Material Puncture/Hole (1504); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/13/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e315 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 categories, pressure dome membrane leak and alarm #1: air detected.No trends were detected for these complaint categories.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 blood leak from the collect pressure dome.The customer reported that following an alarm #1: air detected alarm in the collect line, the customer flushed the line at the needle-free injection port and "popped" the collect pressure dome causing a leak onto the pump deck.The customer stated that the treatment had just finished purging air after 315 ml of whole blood processed.The customer was advised to abort the treatment with no blood volume returned to the patient.However, the customer reported that she wanted to return the blood volume back to the patient via a manual return.The customer stated that the patient's line was clamped at this time.The customer reported that the patient was in stable condition.The customer was instructed on how to access the abort treatment option and on how to empty the contents of the bowl into the return bag via the operator's manual.It was recommended to the customer to clamp the collect line with hemostats just above and below the burst collect pressure dome.The customer reported that she understood and stated that she now needed to perform the manual return and to notify the patient's provider, thus she was not able to provide any further information.The customer stated that she would call back if any further assistance was needed.The kit was not returned for investigation.

• 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: 5784416
• MDR Text Key: 50093760
• Report Number: 2523595-2016-00160
• 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
• Report Date: 06/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 03/01/2018
• Device Lot Number: E315-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2016
• 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