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

Catalog Number CLXUSA

Device Problems Bent (1059); Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Physical Property Issue (3008); Positioning Problem (3009)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e341 was reviewed.There were no non-conformances related to the complaint.This lot met all release requirements.The (b)(4) lot number was not provided as it was not administered.However, a review of all (b)(4) lots manufactured since january 2013 was performed.No trends or nonconformances related to the complaint were noted.Trends were reviewed for complaint category centrifuge bowl leak/break and no trend was detected for this category.This assessment is based on information available at the time of the investigation.At the time of this report, the returned product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.(b)(4).

Event Description

Customer called to report that during a patient treatment the centrifuge bowl dislodged from the bowl holder, spun inside the chamber and "shattered".Customer stated this event also damaged the leak detector strip.Customer stated that no alarms occurred.Customer also stated the patient was fine and that they had only processed 200 ml of blood.On a follow-up call, customer reported the bottom of the centrifuge bowl holder, where the tabs of the centrifuge bowl are inserted, was bent and another bowl cannot be seated into the bowl holder.Customer's internal biomed will evaluate the instrument and perform fix and cleanup.Customer will return the kit for investigation and submitted photos for evaluation.

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 approximately 200 ml of whole blood was processed at the time the centrifuge bowl break occurred.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 the complaint kit and photographs for investigation.

Manufacturer Narrative

On 30 jul 2020 (b)(4) was notified by the fda that the supplemental report for submission 2523595-2017-00247 was received; however, no record of the initial report was recorded in the system.Upon further review it was identified that the mallinckrodt employee inadvertently submitted the supplemental report associated with 2523595-2016-00247 under the incorrect manufacturer report number (i.E., 2523595-2017-00247).As a result, mallinckrodt is resubmitting the supplemental report under the correct manufacturer report number.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 e341 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot e341 shows no trends.Trends were reviewed for complaint category, centrifuge bowl leak/break.No trends were detected for this complaint category.The complaint kit and photographs were returned for evaluation.A review of the photographs verify the centrifuge bowl broke during the ecp treatment.The base of the centrifuge bowl was still secured into the bowl holder on the cellex instrument.Examination of the returned kit showed the outer centrifuge bowl has separated from the bowl base.The separation occurred around the circumference of the outer bowl.The centrifuge bowl was cross sectioned and the weld was verified to be complete, indicating the centrifuge bowl break occurred in the material and not at the weld joint.A material trace of the bowl assembly and its components used to build lot e341 found no related non-conformances.A device history record review of kit lot e341 did not identify any related non-conformances and this kit lot had passed all lot release testing.The root cause of the centrifuge bowl break could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Ttqms: (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: 6086477
• MDR Text Key: 59878043
• Report Number: 2523595-2016-00247
• 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: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 12/08/2020

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: 08/01/2018
• Device Catalogue Number: CLXUSA
• Device Lot Number: E341
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/24/2016
• Initial Date Manufacturer Received: 10/14/2016
• Initial Date FDA Received: 11/08/2016
• Supplement Dates Manufacturer Received: 12/28/2016
• Supplement Dates FDA Received: 12/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1