MAUDE Adverse Event Report: THERAKOS THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Lot Number E325 - KIT

Device Problems Partial Blockage (1065); Fluid/Blood Leak (1250); Cut In Material (2454)

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

Event Date 08/18/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e325 was reviewed.There were no non-conformances.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 tubing leak, alarm #17: system pressure and alarm #18: return pressure and no trend was detected for these categories.This assessment is based on information available at the time of the investigation.The evaluation of the photos, submitted by the customer, was still in progress at the time of this report.A supplemental report will be sent once investigation is complete.(b)(4).Device not returned.

Event Description

Customer called to report tubing leakage of air into the return line at approximately 1199 ml whole blood processed during a double need mode procedure.Customer also reported a blood leak around the collect pump and underneath the pump tube organizer (pto).Customer said she had the collect and return line tubing stretched over the pump deck lying on top of the pump tube organizer between pumps #1 (collect pump) and #5 (a/c pump), and then draped over the left edge of the pump deck above the purple deck handle during the procedure.Customer said the return line had fallen in the "crack" (gap) between the pump deck and the cellex panel cover on the top left edge of the pump deck.Customer said she noticed air entering the return line at the point where the tubing had fallen into this "crack," as well as blood accumulating around the collect pump and under the pto.Customer said she pressed the stop button, clamped the patient's lines, and aborted the procedure.Customer said when she lifted the return line out of the "crack," she observed a slice in the tubing that communicated through the tubing wall.Customer stated the patient was not infused any air from the return line.Customer stated there was approximately 3 inches of air in the return line immediately distal to the slice in the return line tubing.Customer said the return line was completely filled with blood and devoid of any air bubbles from the distal edge of this air segment to the tip of the return line where it attaches to the patient's vascular access.The customer stated she believed the air to have entered the return line at the slice in the tubing, but was unsure where the blood leak near the collect pump and under the pto was coming from.Customer said she unloaded the procedural kit, visually inspected the collect pump tubing segment and underside of the pto, but was not able to visually identify a source of the blood leak.Customer said the only alarms experienced during the procedure were a system pressure alarm during purging air and a couple return pressure alarms during the procedure.Customer said the return line had not at any point been caught up in the collect pump or a/c pump head while rotating.Customer said she was able to clean up the blood around the collect pump and pto to her satisfaction and denied the need for service.Customer stated the patient was stable and discharged from the clinic.Customer said she notified the provider of the issue, confirmed no interventions were ordered by the provider.Customer said they drew a set of post set of labs, and that the patient would return tomorrow ((b)(6) 2016) for an ecp treatment.The customer will send photographs for investigation.

Manufacturer Narrative

Service order report, #(b)(4), feedback: the service technician removed the collect pump head and cleaned underneath the pump.The service technician checked the area around all of the other pumps and then successfully performed the system checkout procedure.(b)(4).

Manufacturer Narrative

A photo associated with the complaint was returned for analysis.Review of the photo confirmed a blood leak.However, from the provided photo, the customer reported slice in the tube could not be observed.The cause of the blood leak could not be determined from the information supplied.(b)(4).Device not returned.

• Brand Name: THERAKOS CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street, suite 30; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 5956653
• MDR Text Key: 55334021
• Report Number: 2523595-2016-00199
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2016

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: 05/01/2018
• Device Lot Number: E325 - KIT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/18/2016
• Initial Date FDA Received: 09/16/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 09/30/2016; 10/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2016
• 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