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

Lot Number REQUESTED BUT NOT PROVIDED

Device Problems Leak/Splash (1354); Malposition of Device (2616)

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

Event Date 09/08/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.The kit lot number was requested but not provided; therefore, a batch record review could not be performed.The uvadex lot number was not provided.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or noncoformances related to the complaint were noted.Trends were reviewed for complaint category, pressure dome membrane leak.No trend was detected for this complaint category.However, a corrective and preventive action has already been initiated for complaint category, pressure dome membrane leak.The assessment is based on information available at the time of the investigation.No product was returned for investigation; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.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).

Event Description

The customer reported that the collect pressure dome went out of its position causing a small spillage of saline solution after 20ml of whole blood processed.The pressure dome's membrane was still in place.The customer stated that she had stopped the procedure and repositioned the dome.The customer requested assistance to continue the procedure.The value for the collect pressure was 202 mmhg while the value for the return pressure was 83 mmhg.The customer checked for any blockage in the lines.The customer stated that the clamp on the collect line was closed.When the customer opened the clamp, the collect pressure decreased to 47 mmhg.The customer continued with the procedure.The patient was reported to be in stable condition.Service was not requested at this time.On (b)(6) 2015, the customer stated that they were able to continue with the treatment and that the treatment ended successfully.The patient was stable after the treatment.The kit was not returned for evaluation.

Manufacturer Narrative

The customer reported that the collect pressure dome went out of its position causing a small spillage of saline solution after 20ml of whole blood processed.The pressure dome's membrane was still in place.The customer stated that she had stopped the procedure and repositioned the dome.The customer requested assistance to continue the procedure.The value for the collect pressure was 202 mmhg while the value for the return pressure was 83 mmhg.The customer checked for any blockage in the lines.The customer stated that the clamp on the collect line was closed.When the customer opened the clamp, the collect pressure decreased to 47 mmhg.The customer stated that they were able to continue with the treatment and that the treatment ended successfully.The patient was stable after the treatment.The root cause for the pressure dome leak in this case is operator error.The customer inadvertently left the collect line clamp closed on the collect line at the beginning of the treatment which caused a build up of pressure.This pressure increase caused the pressure dome to be pushed off of its position and leak.(b)(4).

• 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: 5100418
• MDR Text Key: 26917995
• Report Number: 2523595-2015-00254
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Report Date: 09/08/2015

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 Lot Number: REQUESTED BUT NOT PROVIDED
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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