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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/15/2019

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 h333 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h333 shows no trends.Trends were reviewed for complaint categories, tubing leak, and alarm #18: system pressure.No trends were detected for these complaint categories.The customer supplied photographs were used for evaluation.The photographs show a pool of blood on the instrument pump deck and blood splatter around the collect pump head.The source of the blood leak could not be identified from the provided photograph.A material trace of the components used to manufacture kit lot h333 showed no non-conformances.A device history record review did not identify any related non-conformances and this kit lot had passed all lot release testing.No manufacturing related defects were identified through this investigation.A root cause for the tubing leak could not be determined based on the available information.No further action is required at this time.Investigation complete.(b)(4).

Event Description

The customer contacted mallinckrodt to report that they experienced a blood leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.Customer stated that they experienced an alarm #18: system pressure alarm, but were able to successfully troubleshoot the alarm and proceed with the treatment.Blood was reported to have been observed leaking from the collect pump tubing segment.Approximately 914 ml of whole blood had been processed at the time the leak was observed.The treatment was aborted and residual blood within the kit was not returned to the patient.The patient was reported to be in stable condition.The customer provided photographs for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 9469873
• MDR Text Key: 198755538
• Report Number: 2523595-2019-00147
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H333(17)210501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/13/2019

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: 05/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H333
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/13/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR