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

Catalog Number CLXECP

Device Problems Crack (1135); Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 06/24/2020

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 h268 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h268 shows no trends.Trends were reviewed for complaint categories, alarm #53: return line air detected and photoactivation module 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 and smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported at the end of the procedure they received an alarm #53: return line air detected alarm, and removed the tubing from the air detector to bypass the alarm.The ecp treatment was completed and blood was returned to the patient.The customer reported when they were unloading the kit they noticed a crack in the photoactivation module and it was leaking.The customer reported the patient was in stable condition.The customer returned photographs and the smart card data for investigation.

Manufacturer Narrative

The customer provided photographs and the smart card data for investigation.A review of the smart card data did not verify an alarm #53: return line air detected occurred during the procedure; however, it did show an alarm #49: return bag- air detected and alarm #48: treatment bag - air detected alarm occurred at the end of the treatment.The customer provided photographs verify the photoactivation module leak as cracks are seen in two channels and air bubbles are seen within the module.The cracks can allow air to enter the photoactivation module and most likely was the cause of the alarm #49: return bag - air detected and alarm #48: treatment bag- air detected alarms.A material trace of the photoactivation plates used to build lot h268 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.The root cause of the photoactivation module leak was most likely due to the cracks in the photoactivation plate; however, the cause of the cracks could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 10323569
• MDR Text Key: 202025408
• Report Number: 2523595-2020-00084
• 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: 08/27/2020

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: 11/01/2021
• Device Catalogue Number: CLXECP
• Device Lot Number: H268
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2020
• Initial Date FDA Received: 07/24/2020
• Supplement Dates Manufacturer Received: 08/08/2020
• Supplement Dates FDA Received: 08/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 7 YR
• Patient Weight: 26