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

Device Problems Use of Device Problem (1670); Device Contamination with Body Fluid (2317)

Patient Problem No Information (3190)

Event Date 12/15/2014

Event Type  malfunction  

Event Description

Customer reported that a blood prime treatment had been successfully completed.Customer stated that while she was removing the kit from the instrument, some blood spilled from an uncapped line onto the pump deck, near the return pressure dome.Customer stated the blood came from an uncapped line used with the blood prime setup, but that this line was not a part of the therakos disposable kit.Customer requested guidance on how to clean the blood spill and on when to remove the pressure dome from the pump deck.Clinical services specialist (css) advised customer to clean as much blood as possible from the pump deck before removing the pressure dome, then to remove the pressure dome and complete any needed additional cleanup.Css asked customer to call back if additional questions arise.Customer was satisfied with the assistance provided.

Manufacturer Narrative

Therakos is not the manufacturer for the tubing that leaked.This tubing is not part of the therakos kit.This complaint is reportable due to the contamination risk to the operator.This complaint did not relate to a therakos product.It was reported to therakos due to the fact that a therakos instrument and kit were in use at the time of the leak.Since the tubing that leaked was produced by another company and is not part of the therakos-manufactured products, no complaint category trending was done.No therakos kit lot number was reported; therefore, no batch record review was performed.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 therakos product met specifications.(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 baily ave.; buffalo NY 14211
• Manufacturer Contact: 440 us route 22 east,suite 140; bridgewater, NJ 08807
• MDR Report Key: 4373670
• MDR Text Key: 5261021
• Report Number: 2523595-2014-00341
• 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: 12/15/2014

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
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2014
• Initial Date FDA Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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