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

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Output Problem (3005); Noise, Audible (3273)

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

Event Date 06/05/2019

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction photoactivation module leak.Since this reportable malfunction is only associated with the kit, this mdr will only be against the kit.A batch record review for kit lot h213 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h213 for the reported issue shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak? (photoactivation chamber) and photoactivation module leak leak.No trends were detected for each complaint category.This assessment is based on the information available at the time of the investigation.At the time of this report, the analysis of the returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a photoactivation module leak during the treatment procedure.The customer reported hearing a noise from the photoactivation chamber and then received an alarm #8: blood leak? (photoactivation chamber) alarm.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned photographs for investigation.

Manufacturer Narrative

Photographs of the complaint kit were provided by the customer for evaluation.The photographs verify the reported photoactivation module leak as blood is visible at the bottom of the instrument's photoactivation chamber.Further review of the photographs identified a crack in one of photoactivation module channels.A material trace of the photoactivation plates used to build kit lot h213 did not identify any related non-conformances.A device history record review of kit lot h213 did not identify any related non-conformances, and this kit lot had passed all lot release testing.The reported photoactivation module leak occurred due to a crack in the kit's photoactivation plate.However, a cause for the cracked photoactivation plate could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: 041767.P.T.(b)(6) 2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8764357
• MDR Text Key: 204456880
• Report Number: 2523595-2019-00072
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H213
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 60