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

Lot Number D314-KIT

Device Problems Fluid/Blood Leak (1250); Kinked (1339); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 05/14/2015

Event Type  malfunction  

Event Description

The customer called to report a return pressure alarm at 183ml whole blood processed.The customer stated that she has flushed the line but she cannot reset the alarm.The customer stated that there was no clotting or occlusions in any part of the kit.The customer was asked to flush the access line again.When the customer flushed the line, there was a clot at the end of the collect line.It was suggested that the customer abort the treatment procedure with no return of blood products to the patient.However, the customer stated that there was no clotting in other parts of the kit, so the customer opted to continue with the procedure.The customer reset the alarm, but the return pressure alarm continued to occur.The customer was asked to press stop and to check all parts of the kit for any kinked tubing.The customer checked the kit but did not see any kinked tubing.The customer was asked to flush the patient's access line again.When the customer flushed the line, there was a little bit of fibrin clotting at the end of the line.Again, it was suggested to the customer to abort this procedure with no return of blood/products to the patient.The customer opted to continue.It was suggested that the customer try doing a saline bolus into a separate receptacle.The customer attempted to do a saline bolus however, the return pressure alarm continued to occur.It was suggested that the customer recycle the power.However as soon as the instrument resumed the procedure, the return pressure alarm continued.It was suggested that the customer turn the return pump.When the customer did so, a little popping noise was heard.The customer then noted that there was fluid leaking from the return pressure dome.The customer aborted the treatment procedure.The customer stated that the patient was okay.No service order was generated for this event.The smart card will be returned for investigation.

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d314 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.The uvadex lot number was not provided.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, alarm #17: return pressure, clot observed, and pressure dome membrane leak.No trends were detected for these complaint categories.However, a corrective and preventive action was initiated for complaint category, alarm #17: return pressure and is now closed.A corrective and preventive action was initiated for complaint category, pressure dome membrane leak.No corrective and preventive action was initiated for complaint category, clot observed.This assessment is based on information available at the time of the investigation.The smart card has yet to be received by the manufacturer.Once the smart card has been received, an analysis of the smart card will be performed and a supplemental report will be filed when the analysis is complete.(b)(4).Device not returned to manufacturer.

Manufacturer Narrative

The initial medwatch stated that the smart card would be returned for investigation.However, after multiple attempts were made to followup with the customer, no product was returned.If any product is returned in the future, an investigation will be performed at that time and a supplemental report will be filed.No product was received; therefore, it could not be determined if this specific product met specifications.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted through the capa/continuous improvement process.(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: 4816326
• MDR Text Key: 17209574
• Report Number: 2523595-2015-00174
• 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 Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/14/2015

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: 03/01/2017
• Device Lot Number: D314-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2015
• Initial Date FDA Received: 06/03/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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: 63 YR
• Patient Weight: 80