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 No Known Impact Or Consequence To Patient (2692)

Event Date 01/28/2020

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 h250 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h250 shows no trends.Trends were reviewed for complaint categories, alarm #52: collect line air detected and tubing leak.No trends were detected for each 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 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 tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported at the beginning of the treatment they received an alarm #52: collect line air detected alarm and noted air in the collect line.The customer reported they observed blood leaking from the needle-free injection port located on the kit's collect line.The customer aborted the ecp treatment and did not return residual blood to the patient.The customer reported the patient was safe and successfully completed a new treatment after.The customer returned photographs for investigation.

Manufacturer Narrative

The complaint kit with smart card and photographs were returned for investigation.A review of the smart card data verified that blood collection began in double needle mode and an alarm #52: collect line air detected was received before the operator aborted the treatment.The treatment was aborted after 21 ml of whole blood had been processed.The customer provided photograph verifies the tubing leak as blood is seen leaking from the needle-free port on the collect line.Examination of the needle-free port on the collect line showed that the blue insert in the middle of the port was oval rather than circular.The collect line and anticoagulant line were pressure tested to check for leaks and a leak was verified at the needle-free port on the collect line.A material trace of the components used to build lot h250 did not find any non-conformances.A device history record review did not identify any related non-conformances, deviations or equipment maintenance events.This kit lot had passed all lot release testing.An inspection was performed on 33 master retains for finished kits with the same needle-free port lot number, and no issues with the needle-free ports were found.The cellex kit manufacturing process has been updated to include a visual inspection of all needle-free ports to ensure they are circular in shape and exhibit no visible damage.The reported tubing leak was most likely due to the damaged needle-free port.However, the source of needle-free port damage could not be identified through this investigation.No further action is required at this time.This investigation is now complete.(b)(4).14-may-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9759738
• MDR Text Key: 198753548
• Report Number: 2523595-2020-00027
• 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: 05/14/2020

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: 08/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H250
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Initial Date Manufacturer Received: 01/28/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 05/01/2020
• Supplement Dates FDA Received: 05/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1