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

Catalog Number CLXUSA

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/15/2020

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 j320 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j320 shows no trends.Trends were reviewed for complaint categories, alarm #8: blood leak? (photoactivation chamber) and photoactivation module leak.No trends were detected for these complaint categories.The customer returned photographs for evaluation.The provided photographs verify there is a crack in the photoactivation module.The crack occurred on the edge of the plate and runs through one of the channels of the photoactivation module.A material trace of photoactivation plates used to build lot j320 found no related 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 cause of the alarm #8: blood leak? (photoactivation chamber) alarm was due to the leak in the photoactivation chamber.The root cause of the photoactivation module leak was due to a crack in the plate; however, the cause for the crack could not be determined based on the available information.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 they received an alarm #8: blood leak? (photoactivation chamber) alarm following the photoactivation phase of the procedure.The customer checked the photoactivation chamber where they noticed a crack in the photoactivation plate.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported the patient was in stable condition.The customer 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: 10840213
• MDR Text Key: 224637944
• Report Number: 2523595-2020-00122
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J320(17)220401
• Combination Product (y/n): Y
• 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: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2022
• Device Catalogue Number: CLXUSA
• Device Lot Number: J320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/02/2020
• 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: 63 YR
• Patient Weight: 104