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

Lot Number D313/643 - KIT

Device Problems Fluid/Blood Leak (1250); Split (2537); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 05/18/2015

Event Type  malfunction  

Event Description

Customer reported alarm #7: blood leak? (centrifuge?) occurred at 827 ml whole blood processed during a double needle mode treatment, with a visible split in the drive tube just above the sensorized drive tube clamp assembly.The treatment was aborted and the blood was not returned to the patient.Patient was reported to be stable.Service order, (b)(4), was dispatched to clean the centrifuge.The customer agreed to return the smart card for investigation.

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d313 was performed.There were no nonconformances associated with this lot.This 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, drive tube leak/break and alarm #7: blood leak? (centrifuge chamber).No trends were detected.A corrective and preventive action was initiated for complaint category, drive tube leak/break.Service order, (b)(4), was completed.The service technician cleaned up blood from around the bowl area, adjusted the return pump and performed system checkout procedure.This assessment is based on information available at the time of the investigation.The smart card has not yet been received at the time of this report.A supplemental report will be filed when the smart card has been received and analysis has been completed.(b)(4).Not returned.

Manufacturer Narrative

The initial medwatch stated that the smartcard would be returned for investigation.However, multiple attempts were made to follow up with the customer for return of the smart card with no product returned.If any product is returned in the future, an investigation will be performed and a supplemental report will be filed at that time.No product was received 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).

• 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: 4834898
• MDR Text Key: 5941079
• Report Number: 2523595-2015-00168
• 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: 05/18/2015

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: D313/643 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2015
• Initial Date FDA Received: 06/10/2015
• 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: 75 YR
• Patient Weight: 55