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

Lot Number C356-473-KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2015

Event Type  malfunction  

Event Description

The customer reported a blood leak during the reinfuse phase.The customer explained the return tubing was connected to an extension tubing that had a crack in the female connector of the extension tubing.The customer stated that after the buffy coat was collected; the customer started photoactivation followed by disconnecting the patient's collect tubing and no blood leak had occurred.The customer noticed the blood leak after the treatment was completed, when the customer was preparing to disconnect the patient's return tubing.The customer is unsure of the exact amount of blood loss, but was approximately 100 ml.The patient was reported to be in stable condition during treatment and when the treatment was completed.The customer stated they will run a culture on the patient's line and run another cbc post-ecp.The patient was scheduled for another ecp treatment the next day.The customer stated on (b)(6) 2015, that the extension tubing is a hospital protocol for certain patient access and is also required when connecting male/female connectors.No service order was generated and the kit was not returned.

Manufacturer Narrative

Therakos is not the manufacturer for the extension tubing that leaked.This tubing is not part of the therakos kit.This complaint is reportable due to the blood leak from the extension tubing.This complaint does 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.However, a batch record review of the therakos kit, lot c356, was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Since the extension tubing that leaked was produced by another company and is not part of the therakos manufactured products; no complaint category trending was done.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
• Manufacturer Contact: 10 n high st; ste 300; west chester, PA 19380
• MDR Report Key: 4528067
• MDR Text Key: 5539560
• Report Number: 2523595-2015-00041
• 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: 02/03/2015

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: Health Professional
• Device Expiration Date: 11/01/2016
• Device Lot Number: C356-473-KIT
• Other Device ID Number: 10705030100009
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2015
• Initial Date FDA Received: 02/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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: 63 YR
• Patient Weight: 93