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

Model Number 6661

Device Problem Insufficient Information (3190)

Patient Problem Anemia (1706)

Event Date 12/26/2013

Event Type  Other  

Event Description

Customer called to report pt had an adverse reaction during a treatment procedure with cellex instrument.Name and function of complainant: same as reporter.Customer stated they drew a cbc lab and started the pt treatment, during the treatment, the pt stated she felt strange, the prescribing physician evaluated the pt and determined she was fine.Customer stated when they received the stat cbc back, the pt hematocrit was at (b)(6)% at which point the customer ended the treatment and returned the blood back to the pt.Customer stated the pt received two (2) units of blood and will be re-scheduled next week for her ecp treatment.Pt is stable.Customer did not return the kit for investigation.

Manufacturer Narrative

Batch record review of lot b340 was conducted.There were no non conformances related to this issue for this lot.Lot met release requirements.Complaint lot review conducted and one additional c adverse event was reported to date when using this lot.No trends detected.The assessment is based on info available at the time of the investigation.The instrument performed as intended, and even though a low hematocrit or hemoglobin can be secondary to the underlying disease or frequent ecp treatments; a definite root cause could not be determined; however, therakos has elected to report this incident due to the pt's transfusion.Mxp (b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey avenue; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807 ; 9083675452
• MDR Report Key: 3662921
• MDR Text Key: 4200934
• Report Number: 2523595-2014-00033
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/26/2013

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: Health Professional
• Device Expiration Date: 10/01/2015
• Device Model Number: 6661
• Device Lot Number: B340 KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2013
• Initial Date FDA Received: 01/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2013
• 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 Outcome(s): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 53