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

Lot Number E131-KIT

Device Problems Fluid/Blood Leak (1250); Occlusion Within Device (1423); Increase in Pressure (1491); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 08/16/2016

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e131 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, alarm #52: collect line air detected, alarm #16: collect pressure, and pressure dome membrane leak.No trends were detected for these complaint categories.A photo analysis was conducted for this complaint.A review of the photographs confirmed the leak from the system pressure dome.However, the investigation was unable to determine the cause of the leak based only on the photos.A review of the device history record did not identify any related nonconformances.(b)(4).

Event Description

The customer reported that air had come into the patient's collect line after 572 ml of whole blood processed, due to the patient's access not being well placed.The customer stated that an alarm #16: collect pressure alarm occurred.The customer also reported that an alarm #52: collect line air detected alarm occurred for the air that was in the patient's collect line.The customer stated that they were able to resolve this alarm.However, the customer reported that when the air came to the system pressure dome, the pressure dome's membrane "exploded" and there was a leak.The customer stated that the treatment was aborted with no blood/products returned to the patient.The customer reported that the patient's estimated blood loss was approximately 300 ml.The customer stated that the patient was in stable condition and that the blood loss was not a concern.The customer reported that no air went to the patient.The customer stated that they would start a new treatment on another instrument for this patient.The customer reported that they would clean the instrument.Photos were submitted 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: 5948117
• MDR Text Key: 55039352
• Report Number: 2523595-2016-00210
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 06/01/2018
• Device Lot Number: E131-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2016
• 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