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

Model Number CLXUSA

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 06/30/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 h374 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h374 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak (centrifuge chamber), and drive tube leak/break.No trends were detected for each complaint category.The complaint kit and photographs were returned for evaluation.The provided photographs verify a blood leak occurred as blood spray is seen in a band around the centrifuge chamber walls.The drive tube and centrifuge bowl are intact and still secured into the drive tube retainers and centrifuge bowl holder.Examination of the received kit found dried blood on the drive tube component of the kit.The drive tube and centrifuge bowl were pressure tested to check for leaks and no leaks were identified.The returned kit was installed onto a test instrument for dynamic testing.A dyed solution was pumped into the centrifuge bowl and drive tube and the centrifuge was spun at 2400 rpm for 10 minutes.The leak sensor did not alarm during testing and inspection of the centrifuge chamber did not identify any leaks.Testing of the returned kit did not identify a potential leak site.A material trace of the bowl assembly and its components used to build lot h374 found no related non-conformances.A device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.The cause of the alarm #7: blood leak? (centrifuge chamber) was most likely the blood leak in the centrifuge chamber.The root cause of the drive tube leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they received an alarm #7: blood leak (centrifuge chamber) alarm at approximately 185 ml whole blood 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 stable.The customer returned photographs and the kit 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: 10346819
• MDR Text Key: 205688522
• Report Number: 2523595-2020-00089
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H374(17)211101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2020

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: 11/01/2021
• Device Model Number: CLXUSA
• Device Catalogue Number: CLXUSA
• Device Lot Number: H374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2019
• 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