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

Model Number NOT APPLICABLE

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

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

Event Date 05/18/2020

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 h264 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h264 shows no trends.Trends were reviewed for complaint categories, tubing leak and alarm #48: treatment bag - air detected.No trends were detected for each 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 photographs and video 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 tubing leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer reported they noticed air in the treatment bag and aborted the ecp treatment without returning residual blood within the kit to the patient.The customer disconnected the patient and unloaded the pump tubing segments.The customer observed a leak coming from the recirculation pump tubing.The customer reported they received an alarm #48: treatment bag - air detected alarm during prime before the treatment started; however, the alarm was bypassed by removing the tubing from the air detector.The customer reported the patient was in stable condition and would start a new ecp treatment the same day.The customer returned photographs and a video for investigation.

Manufacturer Narrative

The customer provided photographs and a video for investigation.Examination of the photographs verify the tubing leak at the recirculation pump tubing segment.An additional photograph shows the pump tubing segment uninstalled from the cellex instrument pump head and has damage to the tubing.The provided video also verifies a mark on the pump tubing segment.The treatment bag component is filled with air and was most likely due to the leak in the recirculation pump tubing.A material trace of the black stripe tubing used to build lot h264 did not find any non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.It is unlikely that the tubing segment was damaged prior to product release as an in-process leak test is performed on all kits prior to packaging.The size, shape, and location of the observed damage on the pump loop is consistent with damage that occurs if the pump loop tubing is rubbed against the pump head during installation by the end user.The root cause of the damage to the pump loop tubing most likely occurred during installation of the pump loop by the end user.No manufacturing related defects were confirmed during the evaluation.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: 10165805
• MDR Text Key: 198757209
• Report Number: 2523595-2020-00063
• 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: 07/09/2020

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: 10/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H264
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/18/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/24/2020
• Supplement Dates FDA Received: 07/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 48 YR