MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/04/2020

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 j330 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j330 shows no trends.Trends were reviewed for complaint categories, drive tube leak/break 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 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 that they experienced a drive tube leak/break with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that approximately 648 mls of whole blood was processed when they received an alarm #7: blood leak (centrifuge chamber) alarm and a leak on the drive tube was observed.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer returned photographs for investigation.

Manufacturer Narrative

The customer returned photographs for investigation.A review of the photographs verify the drive tube leak as blood is seen leaking down the drive tube.It appears that both drive tube bearings are secured in the retainer clips.The drive tube was locked into the drive tube clamp and the centrifuge bowl appeared to be properly locked into the bowl holder.It is likely that the leak site was near the upper bearing on the drive tube where the drive tube appeared twisted.A known cause of a twisted drive tube is when the drive tube is not rotating freely.There was no blood splatter on the centrifuge frame or the bowl holder arms indicating that the leak was from the drive tube and not the centrifuge bowl.A material trace of the drive tube used to manufacture lot j330 showed no non-conformances.A device history record review did not identify any related non-conformances, deviations or equipment maintenance events.This lot passed all lot release testing.The cause of the alarm #7: blood leak was the drive tube leak.A root cause for the drive tube leak/break could not be determined from the information provided.No further action is required at this time.This investigation is now complete.(b)(4).S.D.A.22-dec-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster NJ 07921
• MDR Report Key: 10948425
• MDR Text Key: 228625896
• Report Number: 2523595-2020-00127
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J330(17)220401
• Combination Product (y/n): Y
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

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: 04/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: J330
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/04/2020
• Initial Date FDA Received: 12/04/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 10 YR
• Patient Weight: 64