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

Lot Number E341-KIT

Device Problems Detachment Of Device Component (1104); Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317)

Patient Problem Blood Loss (2597)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e341 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, pressure dome membrane leak.No trends were detected for this complaint category.Service order report, #(b)(4), feedback: the service technician cleaned around all of the instrument's pressure sensors and underneath all the pump heads.The system checkout procedure was then performed and all tests passed.The instrument was fully functional.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.(b)(4).

Event Description

The customer called to report that at the start of an (b)(6) 2016 treatment, the system pressure dome "popped off" of its sensor and leaked onto the pump deck.The customer stated that they did not call in this event until now.The customer reported that the treatment was aborted with no blood/products returned to the patient.The customer stated that the patient's blood loss was about 40ml or less.The customer reported that the patient was in stable condition.The customer stated that instrument was wiped down after the leak and that they continued to use the instrument without any problems.However, the customer reported that after a completed treatment on (b)(6)2016, they noticed that there was some dried blood underneath the collect pump.Service was requested.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: 6126542
• MDR Text Key: 61102613
• Report Number: 2523595-2016-00267
• 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: 11/23/2016

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: 08/01/2018
• Device Lot Number: E341-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2016
• Initial Date FDA Received: 11/23/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2016
• 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