MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E339 - KIT

Device Problems Unintended Ejection (1234); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e339 was reviewed.There were no non-conformances.This lot met all 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 and no trend was detected for these categories.This assessment is based on information available at the time of the investigation.A photo associated with the complaint was returned for analysis.Review of the photo confirmed a blood leak from the system pressure dome.However, review of the customer supplied photograph was unable to determine the root cause for the leak.(b)(4).

Event Description

Customer called to report the system pressure dome popped off of the transducer and caused a leak.Two hundred and twelve ml of whole blood was processed.Single needle mode.Forty ml/min collect rate.Customer states approximately 10 air detected alarms occurred prior to leak.Patient was disconnected and the treatment was aborted.Customer cleaned the pump deck, rebooted the instrument, installed a new kit and started the patient on another treatment.Patient reported to be stable.The customer will return a photo for investigation.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6079798
• MDR Text Key: 59599878
• Report Number: 2523595-2016-00244
• 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: 10/10/2016

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: E339 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/10/2016
• Initial Date FDA Received: 11/04/2016
• 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
• Patient Age: 39 YR
• Patient Weight: 98