MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Defective Alarm (1014); Break (1069); Noise, Audible (3273)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

A device history review was performed.The instrument has been located at the customer's site since 08/15/2011.The instrument's last preventive maintenance was in 08/03/2016 and the system checkout procedure was successfully completed.The instrument had passed all tests, met all specifications and was operational at the time of last instrument service.A review of complaint category drive tube leak / break was performed and no trends were observed.Subsequent to the reported complaint, instrument service order (b)(4) was issued to evaluate instrument serial number (b)(4).During instrument service, it was determined that the upper drive tube bearing retainer clip was not appropriately rotating.A stationary upper bearing retainer clip does not allow the kit drive tube to flex which could potentially result in a drive tube break / leak.The upper bearing retainer clip was replaced and the instrument successfully completed the system checkout procedure upon completion of instrument service.Complaints are monitored through tracking and trending.If a trend is detected, further investigation will be conducted.Investigation completed.(b)(4).

Event Description

Customer called to report drive tube break during purging air phase of treatment procedure.Customer stated they heard a loud noise coming from the centrifuge, from there it was noted the drive tube had been broken.Customer aborted the kit with no return of blood to the patient.Customer stated no one is injured or splashed with fluids and the patient is in stable condition.Customer stated no alarms during prime or before the break occurred and it was noted that the leak detector strip is damaged.A service request has been recommended.No other requests or concerns at this time.The instrument was not returned for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road po box 9001; hampton, NJ 08827
• MDR Report Key: 6590423
• MDR Text Key: 76142037
• Report Number: 2523595-2017-00093
• Device Sequence Number: 1
• Product Code: LNR
• 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
• Report Date: 05/23/2017

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 Model Number: NOT APPLICABLE
• Device Catalogue Number: CELLEX
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/26/2017
• Initial Date FDA Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 71