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

Lot Number C305-KIT

Device Problems Leak/Splash (1354); Loose or Intermittent Connection (1371); Device Displays Incorrect Message (2591)

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

Event Date 05/06/2014

Event Type  malfunction  

Event Description

Customer called to report a blood leak at the start of photoactivation that the recirculation pump tubing.Procedure went well until the operator noticed blood leaking from the recirculation pump tubing segment.Treatment was aborted.Patient was set up on another instrument.Operators were able to remove the pump and clean underneath it.Customer does not need service at this time.Css asked if during installation, the recirculation pump tubing segment seemed too tight or too loose.Customer stated it was too loose, but she was eventually able to load it.Customer states she received prime 11 alarm x1, reset it, and completed prime.Customer stated she did not see any leaks or kinks and proceeded with treatment.Customer did not return product for investigation.

Manufacturer Narrative

Batch record review of lot c305 was conducted.There were no nonconformities related to this type of event for this lot.Lot met release requirements.Trends have been reviewed for tubing leak complaint category and no trend has been detected; capa (b)(4) was opened to investigate these types of failures.A trend was detected for tubing length complaint category, and capa (b)(4) is currently open to investigate events related to this type of failure.The assessment is based on information available at the time of the investigation.No product was returned for investigation at the time of this report; therefore, it could not be determined if the product met specification based solely on the information provided by the customer.

• 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 ste 140; bridgewater, NJ 08807
• MDR Report Key: 3915388
• MDR Text Key: 4489045
• Report Number: 2523595-2014-00149
• 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: 05/06/2014

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: 01/01/2016
• Device Lot Number: C305-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2014
• Initial Date FDA Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2014
• 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: 31 YR
• Patient Weight: 89