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 11/25/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction alarm #7: blood leak? (centrifuge chamber).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 j116 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot j116 shows no trends.Trends were reviewed for complaint categories, alarm #18: system pressure and alarm# 7: blood leak? (centrifuge chamber).No trends were detected for these complaint categories.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 and smart card is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).P.T.(b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report they received an alarm #7: blood leak? (centrifuge chamber) with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported approximately 121 ml of whole blood was processed when an alarm #18: system pressure alarm occurred, followed by the alarm #7: blood leak? (centrifuge chamber).The customer inspected the centrifuge chamber and noticed a blood leak occurred.The customer could not determine the exact location of the leak.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 and the smart card data for investigation.

Manufacturer Narrative

The customer returned photographs and the smart card data for evaluation.A review of the data on the smart card verified the occurrence of an alarm #18: system pressure alarm after 121 ml of whole blood had been processed.The data shows the operator cycled power to the cellex instrument and an alarm #7: blood leak? (centrifuge chamber) occurred, indicating the leak sensor detected fluid within the centrifuge chamber.The provided photographs verify a blood leak occurred as blood splatter is seen on the centrifuge chamber walls.The photographs show both drive tube bearings appear to be secured into their respective retainer clips; however, there is a twist in the drive tube at the location of the upper drive tube bearing stop.A twist in the drive tube at this location indicates the drive tube was not rotating freely.A material trace of the drive tube used to manufacture lot j116 showed no 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.The cause of the alarm #7: blood leak? (centrifuge chamber) and alarm #18: system pressure alarm was most likely due to the drive tube leak.The exact location of the leak could not be determined based on the available information; therefore, a root cause could not be determined.No further action is required at this time.This investigation is now complete.(b)(4).P.T.(b)(6) 2021.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 11059756
• MDR Text Key: 223817891
• Report Number: 2523595-2020-00134
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): Y
• 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: 01/25/2021

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: 05/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: J116
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 01/07/2021
• Supplement Dates FDA Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 31 YR
• Patient Weight: 80