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 10/19/2019

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 h330 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h330 for the reported issue shows no trends.Trends were reviewed for complaint category, photoactivation module leak.No trends were detected for this complaint category.Photographs of the complaint kit were returned for evaluation.Examination of the provided photographs verify cracks in the photoactivation module and a leak coming from the plate.The photographs show a large amount of air in the treatment bag.The air in the treatment bag is consistent with a photoactivation module leak allowing air to enter the 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.Operators are to blot off the excessive solvent from the tubing before bonding it to the port and also preventing the solvent from dripping onto the plate during the plate assembly.The root cause of the cracks in the photoactivation plate is due to excessive solvent during the tube bonding process by the manufacturing operator.Retraining has been completed for the affected operators to reinforce proper tube bonding instructions.No further action is required at this time.This investigation is now 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.The customer reported the leak was observed at the end of the buffy coat collection phase, prior to the photoactivation phase.The customer stated they noticed the treatment bag was filling up with air.The ecp treatment was aborted and no residual blood within the kit was returned to the patient.The customer stated the patient was stable.The customer reported when examining the photoactivation module they noticed a crack in the photoactivation plate.The customer has returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin, D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 9333409
• MDR Text Key: 198758235
• Report Number: 2523595-2019-00136
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H330(17)210501
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/20/2019
• 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: 43 YR
• Patient Weight: 66