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

Lot Number D339 - KIT

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

Patient Problems Electrolyte Imbalance (2196); Blood Loss (2597); Test Result (2695)

Event Date 11/20/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d339 was performed.There were no nonconformances related to this complaint.This lot met release requirements.The uvadex lot number was not provided, as it was not administered.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, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected.However, a corrective and preventive action has already been initiated for complaint category, drive tube leak/break.Service order, srv-002795, was completed.The service technician confirmed residual blood in the centrifuge and the pump deck surface.The service technician decontaminated both the centrifuge chamber and pump deck surface and completed a system checkout procedure with satisfactory results.This assessment is based on information available at the time of the investigation.No product was returned by the customer for investigation; therefore, it could not be determined if this specific product met specification.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).Not returned.

Event Description

Customer called to report a drive tube leak 10-15 minutes into treatment at approximately 200ml of whole blood processed.Blood leak? (centrifuge) alarm occurred.The customer called back to request service.Service order, srv-002795, was generated.Customer stated the patient has a trifusion central catheter and is stable.Fluids (250ml normal saline) and magnesium (customer was not sure how much magnesium would be provided) were to be given to the patient before the patient left that day.Customer stated no alarms occurred during prime and no alarms occurred during the patient treatment prior to the leak detected alarm sounding.The customer declined to return the kit for further investigation.Clinical services followed up with the customer.According to the customer, the patient arrived for the procedure with a low magnesium level.Magnesium replacement was ordered before the procedure began.The infusion of saline and magnesium was to address the pre-existing patient condition and not provided as medical intervention related to the reported blood leak.No other details or exact laboratory values were available or provided.

• 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: 5294309
• MDR Text Key: 34135061
• Report Number: 2523595-2015-00305
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 10705030100009
• UDI-Public: 10705030100009
• 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
• Type of Report: Initial
• Report Date: 11/20/2015

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: 07/01/2017
• Device Lot Number: D339 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/20/2015
• Initial Date FDA Received: 12/14/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/01/2015
• 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