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

Lot Number D321-KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Misassembly by Users (3133)

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

Event Date 08/21/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d321 was conducted.There were no non-conformances related to the complaint.This lot met all 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 noncoformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #1: air detected, alarm #17: return pressure, alarm #18: system pressure, clot observed, and protocol: assembly or operation.No trend was detected for complaint categories, alarm #17: return pressure, clot observed, and protocol: assembly or operation.A downward trend was detected for complaint categories, alarm #18: system pressure and alarm #1: air detected.A corrective and preventive action was initiated for complaint categories, alarm #17: return pressure and alarm #1: air detected, and is now closed.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).Device not returned to manufacturer.

Event Description

The customer called to report system pressure alarms x2 after elutriation with 1858ml of whole blood processed.The customer confirmed that there was over 200ml in the treatment bag and it contained some red cells.The customer was given instructions on how to start photoactivation.A return pressure alarm occurred.A few minutes into photoactivation, an air detected alarm occurred with collapsed tubing.No air was seen.The customer noted that the centrifuge bowl and return line were clotted.The customer then saw that the anticoagulant (ac) and saline spikes were in the wrong fluids; the ac line was spiked to the saline bag and the saline line was spiked to the ac bag.The customer disconnected both lines from the patient.The customer confirmed that there was no clotting in the treatment bag and chose to continue with photoactivation.The customer was advised to consult with the patient's provider.The customer was given instructions on how to give a manual return of the treatment bag contents once photoactivation was completed.The customer was advised to monitor the patient's vital signs.The customer was also advised to reinfuse the treatment bag slowly through a blood infusion set, and to check for symptoms of hypocalcemia due to the increased anticoagulant volume.The customer verbalized understanding.The estimated patient blood loss and anticoagulant volume reinfused was discussed with the customer and the customer was referred to technical bulletin #8 of the operator's manual.No service order was generated.On (b)(6) 2015, the customer stated that the treatment was completed and the patient tolerated it well with no side effects.They had disconnected all access from the patient and then started a new line in order to return the contents of the treatment bag.The doctor was notified of the patient's status right after treatment.The patient had his next treatment the following morning and did well.The customer has elected not to return the kit for investigation.

• 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: 5068436
• MDR Text Key: 26744396
• Report Number: 2523595-2015-00244
• 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 faci
• Reporter Occupation: Nurse
• Report Date: 08/21/2015

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: 04/01/2017
• Device Lot Number: D321-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2015
• 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: 68 YR
• Patient Weight: 62