MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Device Displays Incorrect Message (2591); Device Dislodged or Dislocated (2923)

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

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e130 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e130 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories alarm #18: system pressure, pressure dome membrane leak, and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the return product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.This case is reportable as a mdr due to the reportable malfunction, pressure dome membrane leak.Since the pressure dome membrane leak is associated with the kit, only one mdr will be filed for this case.(b)(4).

Event Description

Customer called to report a system pressure alarm followed by pressure dome membrane leak during purging air.Customer said the procedure was aborted and no blood was returned to the patient.Customer said upon examining the system pressure dome, she noted the membrane had dislodged from the pressure dome.Customer said the patient was stable and would not require any medical intervention or blood transfusion.Customer submitted photos for evaluation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.The photos indicated that there was a leak on the instrument's pump deck and that the leak was concentrated within the recessed area of the system pressure dome.The photos also showed that the system pressure dome's membrane had become partially dislodged.Based on the fact that the treatment made it through prime and up to the purging air phase, indicated that the system pressure dome's membrane was properly attached to the system pressure dome at the start of the treatment.The root cause for the leak could not be determined based on the available information.The device history record review did not result in any related nonconformances and this kit lot had passed all lot release testing.A material trace of the pressure dome housing assembly and its components used to build this kit lot also did not find any related nonconformances.During the manufacturing process, all pressure dome assemblies are leak tested before the kits are released.They are leak tested twice during the sub assembly of the pressure domes and again as part of the final kit leak and occlusion test.Only those pressure dome assemblies that pass all three leak tests are released.No further action required.This investigation is now completed.(b)(4).Device not returned to manufacturer.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; 53 frontage road; po box 9001; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; po box 9001; 53 frontage road; hampton, NJ 08827
• MDR Report Key: 6393018
• MDR Text Key: 69864255
• Report Number: 2523595-2017-00045
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/08/2017

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: 06/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: E130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/10/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/31/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/25/2016
• 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: 57 YR
• Patient Weight: 81