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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 09/09/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pump tubing organizer (pto) leak.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 j108 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j108 shows no trends.Trends were reviewed for complaint category, pto leak.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 kit and photograph 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 a pump tubing organizer (pto) leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported a blood leak was observed in the pump tubing organizer underneath the blood filter during the photoactivation phase of the procedure.The customer aborted the ecp treatment and did not return residual blood within the kit to the patient.The customer returned the kit and a photograph for investigation.

Manufacturer Narrative

The complaint kit with smart card was returned for evaluation.The smart card data shows the treatment proceeded through the photoactivation phase of the procedure until the operator aborted the treatment.The pump tubing organizer (pto) was the only component of the kit returned for analysis.Examination of the returned pto found dried blood on the right side of the blood filter in the pto.The pto was pressure tested to check for leaks and no leaks were identified.A material trace of the related components used to build lot j108 showed no related non-conformances.The device history record (dhr) review did not result in any related non-conformances and this kit lot passed all lot release testing.The pto leak was verified based on the dried blood found on the inside of the pto; however, pressure testing of the returned pto did not result in a leak.The cause of the pto leak was most likely a weak weld at the blood filter in the pto.The root cause for the weak weld 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: 10657771
• MDR Text Key: 229004038
• Report Number: 2523595-2020-00108
• 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: 11/06/2020

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: 02/01/2022
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: J108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 09/09/2020
• Initial Date FDA Received: 10/09/2020
• Supplement Dates Manufacturer Received: 10/14/2020
• Supplement Dates FDA Received: 11/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 50