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

Device Problems Fluid/Blood Leak (1250); Protective Measures Problem (3015)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/27/2019

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.The kit lot number was not provided; therefore, no batch record review could be performed.Trends were reviewed for complaint categories, alarm #1: 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 photograph 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 they received an alarm #1: air detected alarm and observed blood leaking from the red blood cell pump area.The customer reported approximately 263 ml of whole blood was processed when the leak was observed.The customer aborted the ecp treatment and did not return residual blood to the patient.The customer provided a photograph for evaluation.

Manufacturer Narrative

A photograph was provided by the customer for evaluation.The smart card was not returned, therefore the reported alarm #1: air detected could not be verified.Evaluation of the provided photograph shows that the red cell pump loop is damaged.The photograph verifies the tubing leak as blood is seen on the cellex instrument pump deck.It is unlikely that the tubing segment was damaged prior to product release as an in-process leak test is performed on all kits prior to packaging.The kit lot number was not provided; therefore, a device history record review could not be performed.The size, shape, and location of the observed damage on the pump loop is consistent with damage that occurs if the pump loop tubing is rubbed against the pump head during installation by the end user.The root cause of the damage to the pump loop tubing most likely occurred during installation of the pump loop by the end user.No manufacturing related defects were confirmed during the evaluation.No further action is required at this time.Mc: 048067.P.T.(b)(6) 2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9503171
• MDR Text Key: 198753078
• Report Number: 2523595-2019-00152
• 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: 02/13/2020

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1