MAUDE Adverse Event Report: THERAKOS CELLEX PHOTOPHERESIS SYSTEM

Model Number NOT APPLICABLE

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 12/11/2017

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 f112 was conducted.There were no non-conformances related to the complaint.This lot met all release requirements.A review of kit lot f112 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.The customer provided photographs have been returned for analysis.Review of the customer photographs confirms the reported pressure dome membrane leak.The photographs show that the pressure dome house had disconnected from the instrument's pressure transducer during the treatment.In addition, the photographs show that pressure dome membrane had completely dislodged from the return pressure dome housing resulting in the reported blood leak.According to the complaint description, the leak occurred after the photoactivation phase of the treatment had been completed.The photoactivation phase occurs at the very end of the treatment; therefore, the return line pressure dome assembly had been in place and functioning appropriately for the entire treatment until photoactivation had completed.A material trace of the pressure dome housing assembly and its components used to build lot f112 did not find any non-conformances.The pressure dome membrane can only dislodge from the pressure dome housing if it is under positive pressure.If the pressure dome membrane housing clips are not properly seated around the circumferential groove of the instrument's pressure transducer, the pressure dome membrane could become dislodged from the pressure dome's housing if enough positive pressure is introduced resulting in a leak.However, the seating of the pressure dome housing on the instrument's pressure transducer could not assessed using the customer provided photographs.As a result, the root cause for the pressure dome membrane leak could not be determined based on an assessment of the complaint description, batch record review, complaint trending and customer provided photographs.No further action required.Investigation complete.(b)(4).

Event Description

The customer called to report a pressure dome membrane leak during a treatment.The customer indicated that a blood leak occurred when the return line pressure dome housing had disconnected from the instrument's pressure transducer after the photoactivation phase was completed.The customer immediately clamped the return line and the treatment bag.The contents of the return bag and treatment bag were then manually returned to the patient.The patient was in stable condition and not affected by the incident.The customer has returned photographs of the incident for investigation.

• 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: 7178903
• MDR Text Key: 97761899
• Report Number: 2523595-2018-00006
• Device Sequence Number: 1
• Product Code: LNR
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 01/10/2018

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: CLXECP
• Device Lot Number: F112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/11/2017
• Initial Date FDA Received: 01/10/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2017
• 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: 56 YR
• Patient Weight: 82