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

Lot Number D342-KIT

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 12/03/2015

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot d342 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.The uvadex lot number was not provided as it was not administered.However, a review of all uvadex lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint categories, alarm #1: air detected and tubing leak.No trends were detected for these complaint categories.Service order report, (b)(4), is still pending.A supplemental report will be filed when the service order report is complete.This assessment is based on information available at the time of the investigation.The analysis of the photo is still in progress.A supplemental report will be filed when the analysis of the photo is complete.(b)(4).Device not returned to manufacturer.

Event Description

The customer reported an alarm #1: air detected alarm at 1000 ml of whole blood processed.Air was seen in the return line air detector and the customer noticed that the return filter was dry.It was recommended to the customer to abort the treatment and manually return the blood.During the manual return process, the customer noticed that there was a leak in the red cell pump tubing segment.The treatment was aborted.The customer stated that blood had leaked under the pumps.Service order, (b)(4), was generated to check the instrument.A photo was submitted for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photograph confirmed the detachment of the red cell pump loop tubing from its associated bond connection point.The investigation determined there was a trend in detached tubing associated with kit lot d342.The root cause of the detached tubing was determined to be a manufacturing error that led to a weaker than normal chemical bond at the failure point.Corrective and preventive actions have been initiated to address the issue.A field action was initiated for this issue.A "medical device recall" letter, was sent to all customers in receipt of the affected kit lot number and the acting recall coordinator at the fda ((b)(4)) was notified of the issue via a field action report on 5-january-2016." service order, (b)(4), was dispatched to check the instrument.The feedback from this service order is still pending.An additional supplemental will be filed once this information is received.(b)(4).Device not returned to manufacturer.

Manufacturer Narrative

(b)(4), feedback: the service technician cleaned the pumps and the underside of the pump deck.The system checkout procedure was then succesfully perfomed and the instrument was returned to service.(b)(4).

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS, INC; west chester PA
• Manufacturer (Section G): HARMAC MEDICAL PRODUCTS; 2201 bailey ave; buffalo NY 14211
• Manufacturer Contact: megan vernak ; 53 frontage road; suite 300; hampton, NJ 08827
• MDR Report Key: 5312103
• MDR Text Key: 34693219
• Report Number: 2523595-2015-00326
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/03/2015

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: Nurse
• Device Expiration Date: 07/01/2017
• Device Lot Number: D342-KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/03/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2016; 01/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2015
• 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: 65 YR
• Patient Weight: 56