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 11/15/2018

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 g352 was conducted.There were no non-conformance's related to the complaint.This lot met all release requirements.A review of kit lot g352 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 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 pump tubing organizer (pto) leak during the treatment procedure.The customer stated during the buffy coat collection phase they noticed a blood leak coming from under the pump tubing organizer.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started a new treatment.The customer has returned the kit for investigation.

Manufacturer Narrative

The pump tubing organizer (pto) component of the kit was returned for investigation.Examination of the returned pto found dried blood on the inside of the pto, below the return line filter.The pto was pressurized and held under water and confirmed a leak at the joint between the return line and port on the return line filter.The root cause of the pto leak was most likely manufacturing operator error due to a weak bond joint during the tube bonding process.Retraining has been completed for manufacturing operators who perform this operation.No further action is required at this time.This investigation is now complete.Mc: (b)(4).P.T.01/22/2019,.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 8166033
• MDR Text Key: 130642081
• Report Number: 2523595-2018-00170
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G352(17)200801
• 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: 01/22/2019

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: 08/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Initial Date Manufacturer Received: 11/15/2018
• Initial Date FDA Received: 12/14/2018
• Supplement Dates Manufacturer Received: 01/03/2019
• Supplement Dates FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR