MAUDE Adverse Event Report: THERAKOS INC. THERAKOS CELLEX PHOTOTPHERESIS SYSTEM; CELLEXC

Lot Number C316 - KIT

Device Problems Crack (1135); Leak/Splash (1354); Device Displays Incorrect Message (2591); Noise, Audible (3273)

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

Event Date 07/11/2014

Event Type  malfunction  

Event Description

Customer reported that after the photoactivation phase was completed, a popping noise was heard during final reinfusion, and a centrifuge chamber blood leak alarm then occurred, followed by a system error.Customer did not recall which specific system error had occurred.Customer reported she had checked the photoactivation chamber, confirmed that the blood leak had occurred, and aborted the treatment.Customer stated the treatment volume had been 135 ml.Customer estimated approximately ml of the 135 ml treatment volume was not returned to the patient when the treatment was aborted.Customer stated patient is stable.Customer stated that earlier in the treatment, she had noticed the fluid in the two tubing lines to the treatment bag had appeared to be moving back and forth at times, and she had noticed a squeaking noise from the #4 pump head (recirculating pump).Customer reported the photoactivation time had been calculated to be two minutes.Customer stated the patient's plasma had not appeared to be cloudy and no buffy volume exceeded alarms had occurred.Customer reported acda was used as the anticoagulant at the default 101 ac ratio.Customer reported the disposal kit had already been discarded as biohazardous waste and cannot be returned, and no photos are available.Customer described the leak as being from a crack about two inches long in the middle of one side of the photoactivation module plate.Service order (b)(4) was dispatched.

Manufacturer Narrative

A review of lot c316 was conducted.There were no nonconformances associated with this lot.The lot met release requirements.Trends have been reviewed for this complaint category and no trends have been detected for photoactivation module leak; manufacturer's capa (b)(4) has already been initiated to investigate this type of events.Service order (b)(4) completed: service engineer cleaned photo chamber of blood from cartridge failure; performed system checkout.No further action required.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 product met specification based solely on the information provided by the customer.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOTPHERESIS SYSTEM
• Type of Device: CELLEXC
• 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: 4220357
• MDR Text Key: 17265130
• Report Number: 2523595-2014-00203
• 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: 07/11/2014

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: 04/01/2016
• Device Lot Number: C316 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2014
• Initial Date FDA Received: 08/06/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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: 24 YR
• Patient Weight: 127