MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591); Material Protrusion/Extrusion (2979); Pressure Problem (3012)

Patient Problem Blood Loss (2597)

Event Date 12/14/2016

Event Type  malfunction  

Manufacturer Narrative

System was used for treatment.Kit lot e219 was reviewed.There were no non-conformances.This lot met all release requirements.A review of kit lot e219 shows no trends.Trends were reviewed for complaint categories pressure dome membrane leak, alarm #16: collect pressure and alarm #18: system pressure and no trend was detected for these categories.This assessment is based on the information available at the time of the investigation.At the time of this report, the returned product evaluation has yet to be completed.A supplemental report will be sent once investigation is complete.(b)(4).Device not returned.

Event Description

Several alarm #16: collect pressure reported that were solved by decreasing the collect rate several times until 15 ml/min during purging air phase then, alarm #18: system pressure posted and simultaneously the system pressure dome popped out producing a blood leak.The inspection of the system pressure dome showed that the membrane popped out at 184 ml of whole blood processed (wbp).Procedure was aborted and blood was not returned to the patient.Patient in stable conditions after the incident.Patient had a new treatment directly afterwards.Customer requested service to check instrument and finalize cleaning under pump.Customer submitted photos for evaluation.

Manufacturer Narrative

Based on the analysis of the customer provided photos, a blood leak could be observed.A material trace for the pressure dome used to build the complaint lot did not find any non-conformances.No manufacturing related defects were confirmed during the evaluation.From the photos, blood could be seen on the instrument deck surrounding the centrifuge system pressure sensor, the pump loop and the pump tubing organizer, all indicating that leak is most likely from the pressure dome; however, the root cause of the leak at the pressure dome could not be determined from the information and photos provided.Investigation completed.(b)(4).Device not returned.

• 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: 6245138
• MDR Text Key: 65071674
• Report Number: 2523595-2017-00007
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P860003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/11/2017

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: CLXECP
• Device Lot Number: E219
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2016
• Initial Date FDA Received: 01/12/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2016
• 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: 63 YR
• Patient Weight: 53