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

Model Number NOT APPLICABLE

Device Problems Detachment Of Device Component (1104); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/30/2017

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 f104 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of f104 for the reported issue shows no trends.Trends were reviewed for complaint category, pressure dome membrane leak.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 is still in progress.A supplemental report will be filed when the analysis is complete.(b)(4).Device not returned.

Event Description

Customer called to report the return pressure dome disconnected from the pressure sensor and leaked during the return phase of the treatment procedure.Customer stated they do not recall if an alarm occurred after the leak.Customer aborted the procedure and did not return blood to the patient.Customer stated the patient is stable.The customer has returned a photograph for investigation.

Manufacturer Narrative

A photo analysis was conducted for this complaint.A review of the customer provided photos confirmed the leak.The root cause of the leak could not be determined based on the information provided.A material trace of the pressure dome housing assembly and its components used to build lot f303 did not find any nonconformances.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 ; 53 frontage road; p.o. box 9001; hampton, NJ 08827
• MDR Report Key: 6677936
• MDR Text Key: 79035961
• Report Number: 2523595-2017-00104
• 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: 07/11/2017

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: 01/01/2019
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXECP
• Device Lot Number: F104
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/29/2017
• Supplement Dates Manufacturer Received: 06/28/2017
• Supplement Dates FDA Received: 07/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/18/2017
• 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: 46 YR
• Patient Weight: 61