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

Lot Number C111-KIT

Device Problems Device Slipped (1584); Device Displays Incorrect Message (2591)

Patient Problem Thrombus (2101)

Event Date 05/16/2014

Event Type  malfunction  

Event Description

Customer reported a blood leak at the return pressure sensor.Issue occurred while buffy coat was photoactivating and rbc were returning to patient at 50 ml/min.Because of a poor vein for return, nurse had left the collect line connected to patient (iv catheter).During the rbc return, a collet pressure alarm occurred, so nurse rinsed the collect line with a syringe filled with saline.When nurse pushed the saline into the catheter, the return pressure dome popped up.The nurse then aborted the treatment.Whole blood processed 1510 ml.Volume of rbc in the return bag: 240 ml, not returned to patient.Treatment volume in the treatment bag: 168ml, not returned to patient.Patient's pulse after event: 109 bpm.Nurse informed she was a small clot to the needle of the catheter when she moved it as kit was being discarded.Patient condition: stable.No product was returned for investigation, but photos provided y customer for evaluation.

Manufacturer Narrative

Batch record review of lot c111 was conducted.There were no non conformances related to this lot.Lot met release requirements.Trends have been reviewed for this complaint category and no trend has been detected; however, capa's (b)(4) are already in progress to investigate pressure dome membrane leaks.Service order (b)(4) completed: service engineer replaced the return pressure sensor and performed check out procedure.The assessment is based on information available at the time of the investigation.No product has been returned for investigation and the photo evaluation is still in progress at the time of this report; therefore, final investigation findings are still pending.(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 ave; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east ste 140; bridgewater, NJ 08807
• MDR Report Key: 3941943
• MDR Text Key: 4532209
• Report Number: 2523595-2014-00161
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 05/16/2014

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: 03/01/2016
• Device Lot Number: C111-KIT
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/16/2014
• Initial Date FDA Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2014
• 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