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

Model Number NOT APPLICABLE

Device Problems Crack (1135); Leak/Splash (1354)

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

Event Date 08/15/2019

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 h108 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h108 for the reported issue shows no trends.Trends were reviewed for complaint category, photoactivation module leak.No trends were detected for this 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).

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.Approximately 1120 ml of whole blood was processed at the time the leak was observed.According to the customer, foam was observed in the kit's treatment bag at the end of the photoactivation phase.The ecp treatment was paused and the kit's photoactivation module was removed from the cellex instrument's photoactivation chamber for inspection.Cracks in the kit's photoactivation module and a fluid leak were discovered upon completion of the inspection.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The patient was re-scheduled to receive their ecp treatment the following day.The customer has provided photographs and the kit's smart card data for investigation.

Manufacturer Narrative

Photographs of the complaint kit and the smart card data was returned for evaluation.A review of the smart card data shows the treatment proceeded to the buffy coat collection phase after 1025 ml of whole blood was processed.Photoactivation was completed and then the operator aborted the treatment.Examination of the provided photographs cannot verify the photoactivation module leak; however, show a large amount of foam and air in the treatment bag.The air in the treatment bag is consistent with a photoactivation module leak allowing air to enter the module.An additional photograph shows cracks running across the channel in the photoactivation module.A known cause for cracks in the photoactivation module is due to excessive solvent used during manufacturing.The solvent can cause damage to the photoactivation plate if too much solvent is used and left to set within the plate.It appears the excess solvent is from the bond that joins the black stripe tubing to the port on the photoactivation plate.The root cause of the cracks in the photoactivation plate is most likely due to excessive solvent during the tube bonding process by the manufacturing operator.Retraining has been completed for the affected operators on 06 sep 2019.No further action is required at this time.This investigation is now complete.Mc: 044282.P.T.10/08/2019.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9030612
• MDR Text Key: 193966335
• Report Number: 2523595-2019-00105
• 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: 10/08/2019

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: 02/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H108
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/13/2019
• Supplement Dates Manufacturer Received: 09/18/2019
• Supplement Dates FDA Received: 10/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 25