MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem Insufficient Information (4580)

Event Date 09/08/2020

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 j217 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j217 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 provided photographs for investigation.The smart card was not returned; therefore, the reported alarm #8: blood leak (photoactivation chamber) could not be verified.An alarm #8: blood leak (photoactivation chamber) occurs when the photoactivation chamber leak detector has detected a fluid leak.The provided photographs verify the photoactivation module leak as a crack near the center of the module is visible.The cause of the crack could not be determined from the photographs.A material trace of the photoactivation plates at incoming in process or through complaints used to build lot j217 did not find any previous non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.A root cause for the photoactivation module leak could not be determined from the information provided.No further action required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a photoactivation module leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 1500 mls of whole blood had been processed when an alarm #8: blood leak? (photoactivation chamber) was received during the photoactivation phase of the treatment and the leak was observed in the photoactivation module.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The patient was reported to be in stable condition.The customer discarded the kit and returned photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster, nj
• 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
• MDR Report Key: 10654659
• MDR Text Key: 224637938
• Report Number: 2523595-2020-00106
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/09/2020

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: 03/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: J217
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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