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 11/26/2019

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 h133 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h133 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, smart card and photographs is still in progress.A supplemental report will be filed when the analysis is complete.(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 stated the leak was observed at a tubing joint within the pto.The customer reported approximately 104 ml of whole blood was processed when the leak was observed.The customer aborted the ecp treatment and did not return residual blood to the patient.The customer reported the patient was in stable condition.The customer has returned the kit, smart card, and photographs for investigation.

Manufacturer Narrative

The complaint kit, smart card, and photographs were returned for evaluation.A review of the data recorded on the smart card showed that prime was completed and blood collection began in single needle mode.The treatment proceeded until 104 ml of whole blood was processed when the operator aborted the ecp treatment.The provided photographs verify the leak as blood was observed leaking from the y-connector that joins the plasma line to the treatment bag and return bag inlet lines inside the pump tubing organizer (pto).Examination of the received kit found dried blood inside the pto in the area of the y-connector.The kit was pressure tested to check for leaks and a leak was confirmed at the y-connector and the red stripe tubing.A material trace of the components used to build lot h133 found no related non-conformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The cause for the tubing leak was most likely a weak solvent bond between the y-connector and the red stripe tubing or poor tubing fitment within the y-connector.Although the leak was likely due to a manufacturing defect, a definitive root cause for the leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.Mc: 047732 p.T.14-feb-2020.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 9492716
• MDR Text Key: 219763864
• Report Number: 2523595-2019-00150
• 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: 02/14/2020

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: 06/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: H133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Manufacturer Received: 11/26/2019
• Initial Date FDA Received: 12/19/2019
• Supplement Dates Manufacturer Received: 01/15/2020
• Supplement Dates FDA Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 46 YR