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

Catalog Number CLXECP

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

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

Event Date 07/22/2020

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 j202 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j202 shows no trends.Trends were reviewed for complaint category, alarm #7: blood leak (centrifuge chamber).No trends were detected for this 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 an alarm #7: blood leak (centrifuge chamber) alarm with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer observed a blood leak in the centrifuge chamber.The customer reported the alarm was received during the purging air phase of the procedure and that less than 100 ml of whole blood was processed.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.

Manufacturer Narrative

The customer provided photographs for investigation.A review of the photographs verify a blood leak as a fine mist of blood splatter is seen on the centrifuge chamber walls.The centrifuge bowl and drive tube components of the kit appear to be intact with no visible damage.The photographs show a small amount of blood above the o-ring in the centrifuge bowl, a potential leak site.The reported alarm #7: blood leak? (centrifuge chamber) alarm could not be verified without the smart card data; however, the cause for the alarm is when the centrifuge leak detector senses fluid within the centrifuge chamber.A material trace of the centrifuge bowl used to build lot j202 did not find any 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 definitive origin of the blood leak could not be determined based on the photographs provided; therefore, a root cause could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).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: 10436483
• MDR Text Key: 205689086
• Report Number: 2523595-2020-00094
• 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: 09/24/2020

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: 01/01/2022
• Device Catalogue Number: CLXECP
• Device Lot Number: 416
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2020
• Initial Date FDA Received: 08/21/2020
• Supplement Dates Manufacturer Received: 09/16/2020
• Supplement Dates FDA Received: 09/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 58