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

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Tear, Rip or Hole in Device Packaging (2385); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

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 g311 was conducted.There were no non-conformances related to this complaint.This lot met all release requirements.A review of kit lot g311 for the reported issue shows no trends.Trends were reviewed for complaint categories, tubing leak, alarm #1: air detected, and alarm #18: system pressure.No trends were detected for each 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 tubing leak during the treatment procedure.The customer reported they received an alarm #1: air detected alarm followed by an alarm #18: system pressure alarm.The customer stated they checked the patient's access and observed saline leaking.The customer stated they noticed a hole in the collect line near the patient access.The customer aborted the treatment and did not return blood to the patient.The customer stated the patient was stable and was being started on a new treatment.The customer has returned the kit for investigation.

Manufacturer Narrative

The complaint kit components were returned for analysis.The smartcard was not returned; therefore, no confirmation of the reported alarms could be made.The collect line and anticoagulant line were returned and pressure tested for leaks.The lines were pressurized and held under water confirming the tubing leak in the anticoagulant delivery line.The collect line and anticoagulant line are connected the entire length of this tubing segment except the last four inches of each end.Further examination of the returned product identified that the collect line and anticoagulant line tubing had been separated approximately 26 inches from the end instead of the four inches required during manufacture.The tear in the anticoagulant tubing ran along the axis of the line and was located in an area of the tubing that had been separated.A material trace of the pvc, paratube assembly and its components used to build lot g311 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.Cellex kits are 100% leak tested prior to packaging.A leak of this nature would have been detected during in-process testing; therefore, it is unlikely the tubing tear was present at the time of manufacture.The investigation determined the tear in the tubing most likely occurred when the collect and anticoagulant line tubes were separated resulting in the reported leak.However, it could not be determined why or how the tubing in this segment had been separated based on the available information.No manufacturing related defects were identified through this investigation.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: 7687064
• MDR Text Key: 114424592
• Report Number: 2523595-2018-00110
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G311(17)200201
• 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: 10/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G311
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2018
• Date Manufacturer Received: 09/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1