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 06/07/2018

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 f121 was conducted.There were no non-conformance's associated with this lot.This lot met all release requirements.A review of kit lot f121 for the reported issue shows no trends.Trends were reviewed for complaint category, pump tubing organizer (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 photograph is still in progress.A supplemental report will be filed when the analysis is complete.Mc: (b)(4); p.T.(b)(6) 2018.

Event Description

The customer sent an email to report a pump tubing organizer (pto) leak during the treatment procedure.The customer reported approximately 1500 ml of whole blood was processed when they observed a leak coming from under the pto.The customer reported the leak occurred during the reinfusion phase of the procedure.The customer indicated that blood and uvadex treated cells were reinfused to the patient.The customer reported the patient was stable.The customer has returned a photograph for investigation.

Manufacturer Narrative

Photographs were provided by the customer for evaluation.A review of the photographs show a small amount of plasma or blood visible on the inside surface of the pump tubing organizer (pto).The leak is confirmed based on the photographs provided.The leak is in the area of the blood filter and return line tubing; however, the origin of the leak could not be determined based on the photographs provided.All kits are leak tested prior to packaging.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 pto leak could not be determined based on the available information.No further action is required at this time.This investigation is now complete.(b)(6).P.T.(b)(6) 2018.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• MDR Report Key: 7660010
• MDR Text Key: 113304637
• Report Number: 2523595-2018-00107
• 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: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 07/19/2018

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: Nurse
• Device Expiration Date: 06/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F121
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2018
• Initial Date FDA Received: 07/03/2018
• Supplement Dates Manufacturer Received: 07/11/2018
• Supplement Dates FDA Received: 07/19/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Weight: 60