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

Model Number NOT APPLICABLE

Device Problem Leak/Splash (1354)

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

Event Date 06/29/2018

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 g317 was conducted.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot g317 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 kit and smartcard were returned for investigation.A review of the data recorded on the smartcard revealed a system pressure alarm occurred during the procedure.The received kit was examined and found the system pressure dome diaphragm partially unseated from the pressure dome housing.The unseated system pressure dome diaphragm was cleaned and reinstalled into the housing.The system pressure dome was installed onto a test pressure sensor and fit without any issues.A pressure test was performed while the pressure dome was installed on the sensor and no leaks were identified.The pressure dome membrane leak is confirmed based on the received kit and finding of the diaphragm partially unseated from the housing.The root cause of the leak is most likely improper installation of the pressure dome by the user.If the pressure dome is not properly seated and latched around the pressure sensor, the system pressure may force the diaphragm to detach from the housing resulting in a leak.No further action is required at this time.This investigation is now complete.(b)(4).(b)(6) 2018.

Event Description

The customer called to report a pressure dome membrane leak during the treatment procedure.The customer stated the leak occurred during the purging air phase of the procedure and approximately 160 ml of whole blood had been processed.The customer reported the leak was coming from the system pressure dome.The customer aborted the procedure and did not return blood to the patient.The customer stated the patient was stable and started treatment on another instrument.The customer has returned the kit and smartcard for investigation.

• Brand Name: CELLEX PHOTOPHERESIS SYSTEM
• Type of Device: CELLEX PHOTOPHERESIS SYSTEM
• Manufacturer (Section D): THERAKOS, INC.; bedminster NJ 07921
• Manufacturer (Section G): MALLINCKRODT PHARMACEUTICALS IRELAND LIMITED; college business & tech park; cruiserath road; blanchardstown, dublin D15 T X2V; EI D15 TX2V
• Manufacturer Contact: megan vernak ; 1425 us route 206; bedminster, NJ 07921
• MDR Report Key: 7705337
• MDR Text Key: 114728854
• Report Number: 2523595-2018-00116
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)G317(17)200201
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2018

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: Health Professional
• Device Expiration Date: 02/01/2020
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: G317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2018
• Initial Date FDA Received: 07/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2018
• 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: 82