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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 02/17/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 h357 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h357 for the reported issue shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.Photographs of the complaint kit were returned for evaluation.A review of the customer provided photographs verify the tubing leak as the clear tubing has disconnected from the tri-connector.The clear tubing is bonded to the tri-connector during manufacturing.A material trace of the tri-connector and clear tubing used to manufacture kit lot h357 showed no 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 tubing becoming disconnected was most likely a weak solvent bond joint between the clear tubing and tri-connector.The root cause of the leak was most likely a manufacturing operator error during the tube bonding process.Retraining has been completed for all bonding operators.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 tubing leak with their cellex photopheresis kit ("kit") after an extracorporeal photopheresis (ecp) treatment was successfully completed.The clear tubing segment disconnected from the tri-connector of the drive tube component when unloading the kit.No patient was connected to the kit when the leak occurred.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: 9845766
• MDR Text Key: 198753705
• Report Number: 2523595-2020-00041
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H357(17)210901
• 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: 03/17/2020

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: 09/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H357
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/17/2020
• Initial Date FDA Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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