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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Dislodged or Dislocated (2923)

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

Event Date 04/11/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction of the tubing leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review of kit lot e361 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e361 for the reported complaint issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.This assessment is based on the information available at this time of the investigation.At the time of this report, the analysis of the photo is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report a tubing leak at the end of buffy coat collection, prior to the beginning of photoactivation.Customer stated at the time the recirculation pump began to spin during the mixing process, the pump tubing segment became dislodged from the pump tubing organizer.Customer stated blood leaked onto the pump deck, underneath the recirculation pump, and pump tubing organizer.Customer aborted the treatment and did not return any blood or fluids to the patient.Customer stated the patient was stable and would not require any medical intervention.Customer has returned a photograph for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.The photo shows the recirculation pump tube broken or detached near the pump tubing organizer (pto).The cause of the leak is the broken/detached recirculation pump tubing.The root cause of the leak could not be determined based on the information provided.The device history record review did not result in any related nonconformances and this kit lot had passed all lot release testing.No further action required.This investigation is now complete.(b)(4).Device not returned.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6557631
• MDR Text Key: 75017023
• Report Number: 2523595-2017-00075
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E361(17)181001
• 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
• Report Date: 06/02/2017

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: 10/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E361
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/11/2017
• Initial Date FDA Received: 05/10/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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
• Patient Age: 66 YR
• Patient Weight: 62