MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Leak/Splash (1354); Split (2537); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 05/24/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction drive tube leak/break.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 f302 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of f302 for the reported issue shows no trends.Trends were reviewed for complaint categories, drive tube leak/break, alarm #7: blood leak (centrifuge chamber), and alarm #1: air detected.No trends were detected for these complaint categories.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

Customer called to report a drive tube leak during the procedure.Customer stated at the time of the leak, the instrument was in a paused state due to an air detected alarm that was reset.Approximately 700 ml whole blood was processed when the leak occurred and the customer received an alarm #7 blood leak (centrifuge chamber).The customer aborted the procedure and did not return blood to the patient.Customer stated upon inspection of the centrifuge chamber a large slit was observed down the length of the drive tube.Customer stated the centrifuge bowl, drive tube, upper and lower drive tube bearings remained installed and intact.Customer stated they did not identify any damaged parts or components within the centrifuge chamber.Customer stated the patient was stable and would not require any medical intervention or blood transfusion.Customer stated they will not be returning product; however, has returned photographs for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the photos confirmed the leak.Further examination of the photos verified a slit along the drive tube that is most likely the cause of the leak.The root cause of the slit along the drive tube 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; hampton NJ
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6658317
• MDR Text Key: 78259673
• Report Number: 2523595-2017-00103
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F302(17)190101
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Expiration Date: 01/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F302
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2017
• Initial Date FDA Received: 06/21/2017
• Supplement Dates Manufacturer Received: 06/13/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2017
• 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: 74 YR
• Patient Weight: 80