MAUDE Adverse Event Report: THERAKOS INC. CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

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

Event Date 07/17/2020

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction tubing 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 j310 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot j310 shows no trends.Trends were reviewed for complaint category, tubing 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 kit is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).S.D.A.(b)(6) 2020.

Event Description

The customer contacted mallinckrodt to report that they experienced a tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated that they observed a leak from the return bag prior to 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 for investigation.

Manufacturer Narrative

The customer returned the kit with smart card for investigation.A review of the smart card data showed that the prime phase was completed and blood collection began in single needle mode.The treatment proceeded through the photoactivation phase of the procedure with 1460 mls of whole blood processed, until multiple alarm #49: return bag - air detected alarms occurred and the operator aborted the treatment.The received kit was intact and still configured in single needle mode.The return bag was pressure tested to check for leaks and a leak was verified within the frosted sep bushing that connects the tubing between the return bag and the spike port.A small cut/tear was found within the frosted sep bushing.All cellex kits are leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the tubing damage was present at the time of manufacture.A material trace of the port used to manufacture lot j310 showed no non-conformances.A device history record review did not result in any related non-conformances.This kit lot had passed all lot release testing.A root cause for the tubing 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).S.D.A.10-sep-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS INC.; bedminster, nj
• MDR Report Key: 10406489
• MDR Text Key: 205540934
• Report Number: 2523595-2020-00093
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)J310(17)220201
• 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
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

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: CLXUSA
• Device Lot Number: J310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Manufacturer Received: 07/17/2020
• Initial Date FDA Received: 08/14/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1