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

Lot Number C107-KIT

Device Problem Free or Unrestricted Flow (2945)

Patient Problem Dyspnea (1816)

Event Date 05/05/2014

Event Type  malfunction  

Event Description

Customer called to report a complaint in a procedure.Customer stated that there were multiple alarms at 1000ml whole blood processed (wbp): air in the collect line (due to kink in the pt access line); system pressure alarm; air in the ac-line, multiple times.Customer reduced the cbp target to 1200ml.Customer then noticed the return bag was completely empty, and air was going to the pt.Customer immediately aborted the treatment.No blood was returned to the pt.Pt reported not feeling well: fast breathing - exitation.A physician and the nurses performed add'l actions: more extensive monitoring; bp: 138/87 and stable, oxygen, ecg: sinus rhythm - biphasic p-waves and blood gases.Pt recovered well, but will stay overnight for observation.No add'l investigations - next procedure planned/foreseen for the following day.Customer stated they did not trust to use the machine without inspection.Service order (b)(4) was dispatched per customer's request.It was difficult to collect clear info, as customer was taking care of the pt.Customer found it hard to remember what happened exactly during treatment, but will be sending the smart card for eval.Update - (b)(6) 2014: css called back customer: pt is doing fine, no problems, stable condition.She received another successful ecp treatment earlier today.

Manufacturer Narrative

Batch record review of lot c107 was conducted.There were no non conformances related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and event type, and no trend has been detected.However, capa (b)(4) has already been opened to investigate cellex's system pressure alarms.Service order (b)(4) completed: tested and found return pressure sensor out of calibration, therefore service engineer changed pressure sensor.Service engineer found all pumps were running too high, ran checkout procedure and calibrated all sensors.The assessment is based on info available at the time of the investigation.No root cause could be determined at this time as investigation is still in progress.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOTPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; ste 140; bridgewater, NJ 08807
• MDR Report Key: 3876830
• MDR Text Key: 4462957
• Report Number: 2523595-2014-00142
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P680003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/05/2014

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: 02/01/2016
• Device Lot Number: C107-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2014
• Initial Date FDA Received: 05/15/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2014
• 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): Hospitalization; Required Intervention