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 04/12/2018

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 g302 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g302 for the reported issue 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 returned photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer called to report a tubing leak during the treatment procedure.The customer stated approximately 400 ml of whole blood had been processed when they noticed the blood filter within the pump tubing organizer was almost empty.The customer stated they noticed blood leaking from the tubing around the return pump.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable.The customer has returned photographs for investigation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.A review of the customer provided photographs verifies that a leak had occurred within the pump tubing organizer (pto).The photographs provided show the leak between the return pump tubing and return output occluder; however, the exact location of the leak could not be determined based on the photographs provided.A material trace of the tubing used to manufacture lot g302 found no related nonconformances.A device history record review did not identify any related non-conformances, and this kit lot had passed all lot release testing.The root cause of 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).

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7508208
• MDR Text Key: 108370255
• Report Number: 2523595-2018-00086
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G302(17)200101
• 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: 05/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G302
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR