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

Model Number NOT APPLICABLE

Device Problems Break (1069); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2017

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 f308 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of f308 for the reported issue shows no trends.Trends were reviewed for complaint category, drive tube leak/break.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 photos and returned kit 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 break during the purging air phase of the treatment procedure.At the time of the drive tube break, approximately 151 ml of whole blood had been processed.The customer received an alarm #7: blood leak (centrifuge chamber) when the break occurred.Customer stated the drive tube broke between the upper and lower drive tube bearings.Customer stated the patient was stable pre, during and post incident.The customer has returned photographs and the kit for investigation.

Manufacturer Narrative

Manufacturer contact address revised.The centrifuge bowl and drive tube component of the complaint kit were returned for analysis, in addition to the smartcard and customer provided photographs.Review of the smartcard data confirmed the occurrence of a blood leak (centrifuge chamber) alarm.The drive tube shaft was examined and found the upper drive tube bearing was missing, as stated by the customer the upper bearing broke apart.The upper bearing stop was properly adhered to the drive tube and had visible rotational wear.Based on the rotational wear observed on the returned drive tube and the customer's description of the broken upper drive tube bearing, the probable root cause of the drive tube break was improper installation of the drive tube upper bearing into the centrifuge's upper bearing retainer clip by the end user.Misload of the upper bearing into the upper bearing retainer clip can result in movement of the bearing down to the middle of the drive tube shaft due to centripetal force.The rotational wear of the drive tube in conjunction with the repositioned drive tube bearing likely resulted in an impact with the centrifuge chamber wall; thus, causing the upper bearing and drive tube shaft to break.This investigation is now complete.(b)(4).(b)(6) 2017.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; hampton NJ 08827
• Manufacturer (Section G): THERAKOS, INC.; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; p.o. box 9001; bedminster, NJ 07921
• MDR Report Key: 6694571
• MDR Text Key: 79771780
• Report Number: 2523595-2017-00116
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F308(17)190201
• 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: 08/16/2017

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: 02/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/08/2017
• Initial Date FDA Received: 07/07/2017
• Supplement Dates Manufacturer Received: 07/18/2017
• Supplement Dates FDA Received: 08/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2017
• 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: 65 YR
• Patient Weight: 91