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

Lot Number D334-KIT

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371)

Patient Problems Anemia (1706); Blood Loss (2597); Test Result (2695)

Event Date 11/10/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d334 was conducted.There were no non-conformances 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 non-conformances related to the complaint were noted.Trends were reviewed for complaint categories, tubing leak and anemia.No trends were detected for these categories.This assessment is based on information available at the time of the investigation.At the time of this report, the kit and smart card have not been received.A supplemental report will be filed when the kit and smart card are received and their analysis is complete.(b)(4).

Event Description

The customer called to report a blood leak from the pump tubing organizer (pto) on (b)(6) 2015.The customer explained that she was collecting the buffy coat and was strumming the tubing that enters into the hematocrit sensor when the tubing came out of the pto very easily.The customer needed assistance with performing a manual return.The customer returned only the contents of the centrifuge bowl and return bag to the patient.The customer stated that the patient was stable and experienced very minimal blood loss.In an update received on november 25, 2015, the customer stated that they saw the patient on (b)(6) 2015.The patient was stable.However the patient's hematocrit dropped from 31% on (b)(6) to 28.2% on (b)(6).There was no known medical intervention required.The customer explained that this has happened before so they could not be sure if the hematocrit drop was due to the aborted treatment or not.The customer agreed to send a portion of the kit (hematocrit sensor with detached tubing) and smart card for investigation.

Manufacturer Narrative

The initial medwatch stated that the kit and smart card were to be returned.However, upon investigation, the kit and smart card were found to have been lost in transit by the shipper.A follow up investigation was conducted by the shipper to locate these items but they could not be found.If the kit and smart card are recovered at any time a supplemental report will be filed when their analysis is complete.(b)(4).Device not returned to manufacturer.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: dianna inguanzo ; 10 north high street; suite 300; west chester, PA 19380
• MDR Report Key: 5269181
• MDR Text Key: 33016895
• Report Number: 2523595-2015-00302
• 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: 11/10/2015

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: 06/01/2017
• Device Lot Number: D334-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2015
• Initial Date FDA Received: 12/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2015
• 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: 61 YR
• Patient Weight: 69