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

Catalog Number CLXECP

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/05/2020

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 h169 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h169 shows no trends.Trends were reviewed for complaint category, tubing leak.No trends were detected for this complaint category.Photographs were provided by the customer for evaluation.Examination of the photographs verify the tubing leak as there is a cut in the yellow striped tubing that runs from the pump tubing organizer (pto) into the centrifuge chamber.The customer reported the damage to the tubing occurred during the treatment when the tubing was inadvertently pinched by the red blood cell pump head as it rotated.The root cause of the tubing leak was most likely caused by damage to the yellow stripe tubing as it was pinched by the rotating pump head.The cause of the tubing becoming pinched by the pump head could not be determined based on the available information.No manufacturing related defects were confirmed during the evaluation.No further action is required at this time.This investigation is now complete.Comp (b)(4).P.T.16-dec-2020.

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 during the blood collection phase of the procedure they observed a leak coming from the plasma tubing.The customer reported during the treatment the tubing was pinched by the pump head assembly.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: 11019928
• MDR Text Key: 222327055
• Report Number: 2523595-2020-00132
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• Reporter Country Code: PO
• 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: 12/16/2020

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: 12/01/2021
• Device Catalogue Number: CLXECP
• Device Lot Number: H169
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2020
• Initial Date FDA Received: 12/16/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2019
• 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