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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2019

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 h336 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot h336 for the reported issue 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.Mc: (b)(4).P.T.(b)(6) 2019.

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 approximately 450 ml of whole blood was processed when they noticed blood leaking from underneath the pto.The ecp treatment was aborted and no blood was returned to the patient.The customer stated the patient was stable.The customer has returned the kit and a photograph for investigation.

Manufacturer Narrative

The complaint kit and a photograph was returned for investigation.A review of the customer provided photograph shows the pump tubing organizer (pto) installed on the pump deck of the customer's instrument.The photograph verifies the pto leak as blood is seen leaking onto the instrument pump deck.Examination of the returned kit found dried blood inside the pto.The blood filter from the pto was pressure tested to check for leaks and confirmed a leak from the upper left hand corner of the filter.The result of the pressure test indicates a leak in the weld between the two halves of the blood filter.A material trace of the related components used to build lot h336 did not find any nonconformances.The cause of the leak was most likely due to a weak weld between the filter cover and base.The root cause of 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.Mc: 046629, p.T.04-jan-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9359388
• MDR Text Key: 221219873
• Report Number: 2523595-2019-00138
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H336(17)210601
• 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: 01/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H336
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2019
• Date Manufacturer Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR