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

Catalog Number CLXECP

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction centrifuge bowl 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 h168 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h168 shows no trends.Trends were reviewed for complaint categories, alarm #7: blood leak? (centrifuge chamber), centrifuge bowl leak/break.No trends were detected for each complaint category.The customer returned photographs for evaluation.The supplied photographs verify the centrifuge bowl leaked as blood splatter is seen on the centrifuge chamber walls.The bowl appears to be intact and still locked into the bowl holder of the cellex instrument.The photographs show a crack running across the side of the centrifuge bowl.A material trace of the bowl assembly and its components used to build lot h168 found no related non-conformances.A device history record review of kit lot h168 did not identify any related non-conformances and this kit lot had passed all lot release testing.The cause of the centrifuge bowl leak was most likely due to the crack in the outer centrifuge bowl.The root cause of the crack in the centrifuge bowl 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 centrifuge bowl 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) and inspected the centrifuge chamber where a leak was observed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer reported approximately 90 ml of whole blood was processed at the time the leak occurred.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: 10323818
• MDR Text Key: 209846381
• Report Number: 2523595-2020-00087
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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: 07/24/2020

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: 12/01/2021
• Device Catalogue Number: CLXECP
• Device Lot Number: H168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 07/24/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2019
• 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