MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Contamination with Body Fluid (2317); Device Displays Incorrect Message (2591)

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

Event Date 01/12/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.A batch record review of kit lot e363 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot e363 for the reported complaint issue shows no trends.Trends were reviewed for complaint categories drive tube leak/break and alarm #7: blood leak (centrifuge chamber), and no trend was detected for these categories.Analysis of the customer supplied photo, customer description of blood on the centrifuge wall and the returned kit and review of the returned drive tube confirmed a leak and that the bearing stops were in the correct location and firmly attached to the drive tube.The analysis performed indicated that the failure is not due to bearing stop delamination.Review of the photos of the returned kit molding's observations that the upper bearing stop was wearing against something while being rotated, creating the grove and the worn down appearance of the upper bearing stop this wearing caused the drive tube to twist and break.The root cause of the twisting is most likely that the drive tube was not rotating freely within the bearing.This is most likely due to the bearing stop being loaded in the bearing retainer instead of the bearing itself.The requested device history record (dhr) review did not result in any related nonconformances.This lot passed all lot release testing, no manufacturing defects were confirmed.No further actions required.This case is reportable as a mdr due to the reportable malfunction, drive tube leak/break.Since the drive tube leak/break is only associated with the kit, only one mdr will be filed for this case.Investigation complete.(b)(4).

Event Description

Customer called to report blood leak in centrifuge during treatment procedure.Customer stated that at about 165 ml whole blood processed, alarm #7: blood leak (centrifuge chamber) occurred.Upon opening the centrifuge, they noted blood on the centrifuge wall.Customer aborted the procedure with no return of blood/products to the patient.Customer reported no other alarms occurred prior to blood leak.Customer stated the drive tube was still intact.Customer will return the kit for investigation, and will also send pictures.

• 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 30; west chester PA 19380
• Manufacturer Contact: megan vernak ; 53 frontage road; po box 9001; hampton, NJ 08827
• MDR Report Key: 6321722
• MDR Text Key: 67418993
• Report Number: 2523595-2017-00022
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)E363(17)181001
• 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: 02/07/2017

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: 10/01/2018
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: E363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2017
• Initial Date FDA Received: 02/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2016
• 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: 31 YR
• Patient Weight: 83