MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Device Alarm System (1012); Leak/Splash (1354)

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

Event Date 09/20/2017

Event Type  malfunction  

Manufacturer Narrative

The system was used for treatment.This case is reportable as a mdr due to the reportable malfunction pressure dome membrane leak.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 f334 was conducted.There were no non-conformances.This lot met all release requirements.A review of f334 for the reported issue shows no trends.Trends were reviewed for complaint category pressure dome membrane leak.No trend was 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 is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).

Event Description

Customer called to report a blood leak from underneath the system pressure dome, approximately 20 minutes into the procedure.The customer mentioned that there were no alarms prior to the blood leak.The procedure was aborted without blood return to the patient.Customer stated that no medical intervention was planned or needed for this incident.The patient received a new ecp procedure on a different cellex instrument.The customer confirmed that the patient tolerated the therapy well, and confirmed that the procedure was successfully completed with no issues.The customer has provided photographs of the incident to be investigated.

Manufacturer Narrative

A photograph analysis was conducted for this complaint.Based on the customer provided photographs and the description the pressure dome membrane leak was verified.A review of the photographs show that there is blood on the pump deck, however it is difficult to determine the exact source of the leak.A material trace of the pressure dome housing assembly and its components used to build kit lot e334 did not find any nonconformance's.The device history record review did not result in any related nonconformance's and this kit lot had passed all lot release testing.The pressure dome is leak tested three times during manufacturing; twice at the sub-assembly level and once as part of the finished kit.It is likely the leak would have been detected during testing.The root cause of the reported pressure dome membrane leak could not be determined.No further actions required at this time.Investigation complete.(b)(4).(b)(6) 2017.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS; bedminster NJ
• Manufacturer (Section G): THERAKOS, INC; 10 north high street; suite 300; west chester PA 19380
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 6951986
• MDR Text Key: 90649089
• Report Number: 2523595-2017-00183
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)F334(17)190701
• 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: 12/18/2017

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: 07/01/2017
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: F334
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/20/2017
• Initial Date FDA Received: 10/16/2017
• Supplement Dates Manufacturer Received: 11/21/2017
• Supplement Dates FDA Received: 12/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2017
• 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: 69 YR
• Patient Weight: 74