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

Model Number NOT APPLICABLE

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/21/2019

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.Kit lot h330 was reviewed.There were no non-conformances associated with this lot.This lot met all release requirements.A review of kit lot h330 shows no trends.Trends were reviewed for complaint categories, pressure dome membrane leak, and alarm #18: system pressure.No trends were detected for these complaint categories.An investigation was performed based on the complaint description, the returned kit, and smart card.Review of the data on the returned smart card shows that an alarm #18: system pressure occurred.A leak from the system pressure dome was confirmed upon inspection of the received kit.The leak occurred because the diaphragm was partially unseated.When a pressure dome is not properly attached to its pressure sensor, because one of its latches is not secured in the circumferential groove, the diaphragm of the pressure dome will have room to move and become unseated.Evidence indicates the system pressure dome was most likely not properly installed during use.No further action is required at this time.This investigation is now complete.(b)(4).

Event Description

The customer called to report that they experienced a pressure dome membrane leak with their cellex photopheresis kit ("kit") during an extracorporeal photopheresis (ecp) treatment.The customer stated an alarm #18: system pressure occurred, and during troubleshooting the alarm, they observed blood leaking from the system pressure dome.The blood leak was observed after approximately 206 ml of whole blood had been processed.The ecp procedure was aborted, and the patient was reported to be in stable condition.The customer has returned the kit and smart card 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: 9351306
• MDR Text Key: 198760381
• Report Number: 2523595-2019-00137
• Device Sequence Number: 1
• Product Code: LNR
• UDI-Device Identifier: 20705030200003
• UDI-Public: (01)20705030200003(10)H330(17)210501
• 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: 11/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Model Number: NOT APPLICABLE
• Device Catalogue Number: CLXUSA
• Device Lot Number: H330
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/20/2019
• 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: 61 YR