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

Lot Number C306-KIT

Device Problems Crack (1135); Device Displays Incorrect Message (2591)

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

Event Date 04/25/2014

Event Type  malfunction  

Event Description

Customer called to report a crack in the drive tube after 1371 ml processed.Only other alarm during treatment was a red cell pump alarm at 600 ml processed with a low red cell interface.Ac ratio was changed to 8:1 and flow rates decreased due to red cell pump alarm.Dual needle procedure.Treatment was aborted and no blood was returned to the patient.Service order (b)(4)was dispatched.Customer did not return product for investigation.

Manufacturer Narrative

Batch record review of lot c306 was conducted.There were no non conformances related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for this complaint category and a trend has been detected for drive tube leak/break; however, manufacturer capa (b)(4) has already been opened to investigate cellex's drive tube leak/breaks.Service order (b)(4) feedback is still pending at the time of this report.The assessment is based on information available at the time of the investigation.No product was returned for investigation and the service order feedback is still pending; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC.; bridgewater NJ
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east; suite 140; bridgewater, NJ 08807
• MDR Report Key: 3959970
• MDR Text Key: 4625493
• Report Number: 2523595-2014-00132
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P680003
• 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
• Report Date: 04/25/2014

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: Health Professional
• Device Expiration Date: 02/01/2016
• Device Lot Number: C306-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2014
• Initial Date FDA Received: 05/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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: 17 YR
• Patient Weight: 95