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

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250); Material Rupture (1546)

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

Event Date 11/19/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane 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 f110 was conducted.There were no non-conformances.This lot met all release requirements.A review of kit lot f110 for the reported issue shows no trends.Trends were reviewed for complaint category, pressure dome membrane 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 customer provided photographs is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

The customer sent an email to report a pressure dome membrane leak during the treatment procedure.The customer stated at approximately 232 ml of whole blood processed, blood leaked from the system pressure dome membrane.The customer stated the membrane disconnected from the dome, and it appears the membrane did not rupture.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was okay.The customer stated a field service engineer inspected the device and did not find any technical problem.The customer has returned photographs for investigation.

Manufacturer Narrative

A photographic analysis was conducted for this complaint.A review of the returned smart card was also completed.A review of the customer provided photographs confirm a blood leak occurred during treatment on the pump deck.Additionally the photograph shows a system pressure dome that is disconnected from the pressure sensor.Based on the description provided by the customer, 232 ml of whole blood was processed at the time the leak occurred, indicating that the pressure dome membrane was attached to the dome housing at the start of the treatment.Furthermore, review of the returned smart card data verified that priming of the kit was completed without incident.A material trace of the pressure dome housing assembly and its components used to build lot f110 found no related nonconformances.The pressure dome assembly is leak tested twice during the sub assembly and once more as part of the final kit leak and occlusion test.The device history record review did not result in any related non-conformances and this kit lot had passed all lot release testing.No manufacturing related issues could be identified through this investigation.The pressure dome membrane can dislodge from the pressure dome housing if it is under positive pressure and not securely attached to the pressure sensor.However, the root cause of the reported system pressure dome membrane leak could not be determined based on the information provided.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
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7127566
• MDR Text Key: 95776571
• Report Number: 2523595-2017-00225
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2018

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: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/20/2017
• Initial Date FDA Received: 12/18/2017
• Supplement Dates Manufacturer Received: 01/09/2018
• Supplement Dates FDA Received: 02/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2017
• 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: 73 YR