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

Lot Number C348 - KIT

Device Problems Detachment Of Device Component (1104); Device Displays Incorrect Message (2591)

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

Event Date 12/09/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot c348 was performed.There were no nonconformances associated with this lot.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, pressure dome membrane leak and alarm #18: system pressure, and no trends were detected.However, a corrective and preventive action has already been initiated for complaint category, pressure dome membrane leak.Photos have not yet been received from the customer.A supplemental report will be filed when analysis of the photos is complete and feedback from service order, (b)(4), is available.(b)(4).

Event Description

Customer called to report that a system pressure dome "popped off" during a treatment immediately during a system pressure alarm.Operator reported the instrument was stopping the bowl as normal during this alarm and she also pressed stop at which point the pressure dome popped and the membrane broke, leaking blood over the pump deck and system pressure sensor.Treatment was at 160 ml whole blood processed and alarm occurred during purging air.Treatment was aborted.Patient was stable and being treated on another instrument.Customer is requesting service for a thorough cleaning and check of the pump deck and system pressure sensor.Service order, (b)(4), was dispatched.

Manufacturer Narrative

(b)(4), was completed: the service technician found blood under the centrifuge transducer.He replaced the centrifuge transducer and gasket.He also replaced the collect and anticoagulent pump heads.System checkout procedure was performed with satisfactory results.Multiple follow-up attempts were made to obtain the pictures but pictures were not sent by the customer.(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: 5317984
• MDR Text Key: 34883824
• Report Number: 2523595-2015-00319
• 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,Followup
• Report Date: 12/09/2015

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: 10/01/2016
• Device Lot Number: C348 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/09/2015
• Initial Date FDA Received: 12/22/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2014
• 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: 28 YR
• Patient Weight: 55